U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals and Clearances
  5. 510(k) Clearances
  6. August 2023 510(K) Clearances
  1. 510(k) Clearances

August 2023 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD August 2023


DEVICE: Maxiocel Chitosan Wound Dressing
Advamedica Inc.                   510(k) NO: K212766(Traditional)
ATTN: Leo  Mavely                 PHONE NO : 1 973 7187575 
Harvard Square, 1 Mifflin Place, SSE DECISION MADE: 24-AUG-23
Cambridge MA  02138               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
Roche Diabetes Care GmbH          510(k) NO: K213131(Traditional)
ATTN: Wolfgang  Handel            PHONE NO : 49 621 7598331 
Sandhofer Strasse 116             SE DECISION MADE: 10-AUG-23
Mannheim  DE 68305                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accu-Chek Solo micropump system with interoperable technology
Roche Diabetes Care GmbH          510(k) NO: K213134(Traditional)
ATTN: Wolfgang  Handel            PHONE NO : 49 621 7598331 
Sandhofer Strasse 116             SE DECISION MADE: 10-AUG-23
Mannheim  DE 68305                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MedicloseTM System
Health Value Creation BV, trading 510(k) NO: K213271(Traditional)
ATTN: Kim  Sondeijker             PHONE NO : 31 43 3882948 
Oxfordlaan 55                     SE DECISION MADE: 31-AUG-23
Maastricht  NL 6229 EV            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MONTAGE Settable, Resorbable Hemostatic Bone Putty
Orthocon, Inc.                    510(k) NO: K213418(Traditional)
ATTN: Howard  Schrayer            PHONE NO : 914 3572600 
1 Bridge Street, Suite 121        SE DECISION MADE: 30-AUG-23
Irvington NY  10533               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
Becton Dickinson and Company      510(k) NO: K213670(Traditional)
ATTN: Katherine Kenner Lemus      PHONE NO : 801 5419274 
1 Becton Drive                    SE DECISION MADE: 25-AUG-23
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alinity h-series System
Abbott Laboratories               510(k) NO: K220031(Traditional)
ATTN: Neha  Vatsyayan             PHONE NO : 408 3134401 
4551 Great America Pkwy           SE DECISION MADE: 04-AUG-23
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
KRONUS, Inc.                      510(k) NO: K220085(Traditional)
ATTN: Delaney  Sauer              PHONE NO : 208 3774800 
170 S. Seneca Springs Way Suite 10SE DECISION MADE: 24-AUG-23
Star ID  83669                    510(k) STATEMENT
                                                    

DEVICE: Monaghan medical filtered mouthpiece kit
Monaghan Medical Corporation      510(k) NO: K220145(Traditional)
ATTN: Cari J Reil                 PHONE NO : 518 5617330 
153 Industrial Boulevard          SE DECISION MADE: 24-AUG-23
Plattsburgh NY  12901             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eco Abutment, Multiunit Abutment
DIO Corporation                   510(k) NO: K220253(Traditional)
ATTN: Cho  Hye-won                PHONE NO : 82 51 7457836 
66, Centumseo-ro                  SE DECISION MADE: 18-AUG-23
Busan  KR 48058                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SQA-iO Sperm Quality Analyzer
Medical Electronic Systems LTD    510(k) NO: K220828(Traditional)
ATTN: Marcia  Deutsch             PHONE NO : 972 54 7708618 
Alon Hatavor 20, Zone 6, Caesarea SE DECISION MADE: 07-AUG-23
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nova HD+
Aura Wellness, LLC                510(k) NO: K220938(Traditional)
ATTN: Scott  Blomberg             PHONE NO : 502 7141993 
11530 Electron Drive              SE DECISION MADE: 22-AUG-23
Louisville KY  40299              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Immunoglobulin G (IgG)
Beckman Coulter Laboratory Systems510(k) NO: K221114(Traditional)
ATTN: Tracy  Jin                  PHONE NO : 86 512 68955129 
No. 181 West Su Hong Road, Suzhou SE DECISION MADE: 02-AUG-23
Suzhou  CN 215021                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Titus Titanium Cervical by SAGICO
SAGICO VA USA, LLC                510(k) NO: K221138(Traditional)
ATTN: James  Gibson               PHONE NO : 813 8150613 
2189 W.Busch Blvd                 SE DECISION MADE: 04-AUG-23
Tampa FL  33612                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: circul™ pro Ring
BodiMetrics, LLC                  510(k) NO: K221361(Traditional)
ATTN: Mark  Goettling             PHONE NO : 818 2686828 
1601 N. Sepulveda Blvd, Suite 839 SE DECISION MADE: 29-AUG-23
Manhattan Beach CA  90266         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
Globus Medical Inc.               510(k) NO: K221894(Traditional)
ATTN: Kelly  Baker                PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 03-AUG-23
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ID NOW COVID-19 2.0
Abbott Diagnostics Scarborough, In510(k) NO: K221925(Dual Track)
ATTN: Jessica E. Stahle           PHONE NO : 207 7306353 
10 Southgate Road                 SE DECISION MADE: 10-AUG-23
Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q21
NeuroField Inc.                   510(k) NO: K221959(Traditional)
ATTN: Nicholas J. Dogris          PHONE NO : 760 8724200 
386 West Lane                     SE DECISION MADE: 31-AUG-23
Bishop CA  93514                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Patient Examination Gloves, Powder Free, Pink Color
Shandong YINGHNG Medical Products 510(k) NO: K222103(Traditional)
ATTN: Emily  Dong                 PHONE NO : 86 53 66136888 
No.15 East Road, Hongrun Industry SE DECISION MADE: 24-AUG-23
Qingzhou  CN 262500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protective Gown AAMI Level 4
Kenpax International Limited      510(k) NO: K222128(Traditional)
ATTN: Solomon  Chen               PHONE NO : 909 4387898 
Flat 5, 5/F, Wing On Plaza, 62 ModSE DECISION MADE: 08-AUG-23
Hong Kong  CN 999077              510(k) STATEMENT
                                                    

DEVICE: HemoScreen Hematology Analyzer
PixCell Medical Technologies, Ltd.510(k) NO: K222148(Traditional)
ATTN: Yaara Ben Yosef             PHONE NO : 972 4 9593516 
6 Hayezira St.                    SE DECISION MADE: 16-AUG-23
Yoknaem Ilit  IL 2069202          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACR Screw System
BioMaterials Korea, Inc           510(k) NO: K222245(Traditional)
ATTN: Young-yeop  Kim             PHONE NO : 82 31 7904511 
#329, #331, #413 150, Jojeong-daerSE DECISION MADE: 21-AUG-23
Hanam-si  KR 12930                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
Siemens Healthcare Diagnostics Inc510(k) NO: K222439(Traditional)
ATTN: Joy  Anoop                  PHONE NO : 516 2323307___ 
511 Benedict Avenue               SE DECISION MADE: 08-AUG-23
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Air Smart Extra Spirometer
FeelLife Health Inc.              510(k) NO: K222443(Traditional)
ATTN: May  Xiao                   PHONE NO : 0755 66867080 
Room 1903, Building A, No.9 FurongSE DECISION MADE: 09-AUG-23
Shenzhen  CN 518104               510(k) STATEMENT
                                                    

DEVICE: Alveoair Digital Spirometer
Roundworks Technologies Private Li510(k) NO: K222525(Traditional)
ATTN: Prashant  Patel             PHONE NO : 91 750 7776273 
Office No. B 302, Building No. B, SE DECISION MADE: 28-AUG-23
Wakad, Pune  IN 411047            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Kiestra IdentifA
Becton, Dickinson and Company     510(k) NO: K222563(Traditional)
ATTN: Laura  Stewart              PHONE NO : 410___ 5044252 
7 Loveton Circle Mail Code 694    SE DECISION MADE: 31-AUG-23
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Premier Resolution System
Trinity Biotech (Primus Corporatio510(k) NO: K222635(Traditional)
ATTN: Kaitlyn  Eastman            PHONE NO : 716 4837423 
4231 E. 75th Terrace              SE DECISION MADE: 04-AUG-23
Kansas City MO  64132             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oral/Enteral Syringe with ENFit connector
Anhui Tiankang Medical Technology 510(k) NO: K222772(Traditional)
ATTN: Zhang  Yong                 PHONE NO : 86 1370 5505106 
No. 228, Weiyi Road, Economic DeveSE DECISION MADE: 17-AUG-23
Tianchang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Feeding Tube
Anhui Tiankang Medical Technology 510(k) NO: K222773(Traditional)
ATTN: Zhang  Yong                 PHONE NO : 86 1370 5505106 
No. 228, Weiyi Road, Economic DeveSE DECISION MADE: 17-AUG-23
Tianchang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 072 Aspiration System
Q’Apel Medical, Inc.              510(k) NO: K222786(Traditional)
ATTN: Kim  Ky                     PHONE NO : 510 8284757 
4245 Technology Drive             SE DECISION MADE: 25-AUG-23
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAVAb IgG II
ABBOTT LABORATORIES               510(k) NO: K222850(Traditional)
ATTN: Dominic  Tunzi              PHONE NO : 224 6683644 
100 Abbott Park Road              SE DECISION MADE: 10-AUG-23
Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BlueStar CGM insulin dose calculator
Welldoc, Inc.                     510(k) NO: K222888(Traditional)
ATTN: Ian  Cadieux                PHONE NO : 619 8940873 
10221 Wincopin Circle, Ste #150   SE DECISION MADE: 11-AUG-23
Columbia MD  21044                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oneday Mini Implant System
Oneday Biotech Co., Ltd.          510(k) NO: K222946(Traditional)
ATTN: Jae Hyun Song               PHONE NO : 82 53 5812835 
135 C Seongseodongro Dalseogu     SE DECISION MADE: 23-AUG-23
Daegu  KR 42721                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioProtect Balloon Implant™ System
BioProtect, Ltd.                  510(k) NO: K222972(Traditional)
ATTN: Itay  Barnea                PHONE NO : 97 52 8677373 
8 Tsor st                         SE DECISION MADE: 25-AUG-23
Tzur Yigal  IL 4486200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs
Sentienx Sdn Bhd                  510(k) NO: K222993(Traditional)
ATTN: Sahrudin Shah Bin Abu Bakar PHONE NO : 60 378 903338 
Lot 7, Jalan Hi-Tech 12, Zon IndusSE DECISION MADE: 18-AUG-23
Kulim  MY 09090                   510(k) STATEMENT
                                                    

DEVICE: Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
Gm Dos Reis Industria E Comerico L510(k) NO: K223114(Traditional)
ATTN: Iara  Guimaraes             PHONE NO : 55 19 37659900 
Avenida Pierre Simon De La Place 6SE DECISION MADE: 02-AUG-23
Campinas  BR 13069320             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MENIX®; MENIX® DUO
S.B.M. SAS (Science & Bio Material510(k) NO: K223122(Traditional)
ATTN: Anne  Cospin-Latapie        PHONE NO : 33 562 422101 
ZI du Monge                       SE DECISION MADE: 03-AUG-23
Lourdes  FR 65100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
Covidien                          510(k) NO: K223130(Traditional)
ATTN: Anila  Tarte                PHONE NO : 978 4966694 
6135 Gunbarrel Avenue             SE DECISION MADE: 30-AUG-23
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VisiRad XR
Imidex Inc.                       510(k) NO: K223133(Traditional)
ATTN: Kris  Zeschin               PHONE NO : 303 9022171___ 
3513 Brighton Blvd., Suites 456 7 SE DECISION MADE: 03-AUG-23
Denver CO  80216                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APS Metal Plate & Screw System
A Plus Biotechnology Co., Ltd     510(k) NO: K223150(Traditional)
ATTN: Frank  Hsu                  PHONE NO : 886 2 22499222 710
2F-2, No. 120, Qiaohe Rd., ZhongheSE DECISION MADE: 24-AUG-23
New Taipei City  TW 23584         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sleepiz One+
Sleepiz AG                        510(k) NO: K223163(Third Party - Traditional)
ATTN: Marta  Stepien              PHONE NO : 41 76 7837350___ 
Hornbachstrasse 23                SE DECISION MADE: 18-AUG-23
Zurich  CH 8008                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Spirair Nasal Septal Strap
Spirair, Inc.                     510(k) NO: K223167(Traditional)
ATTN: James  Kintzing             PHONE NO : 703 9999462 
6084 Monterey Hwy, 108            SE DECISION MADE: 17-AUG-23
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIRAscore
AIRAmed GmbH                      510(k) NO: K223180(Traditional)
ATTN: Maximilian  Stalter         PHONE NO : 49 7071 5393366 
Konrad-Adenauer-Str. 13           SE DECISION MADE: 25-AUG-23
Tübingen  DE 72072                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spinery™ RF Ablation System
Axon Spine Medical System         510(k) NO: K223303(Traditional)
ATTN: Salvatore  Accardo          PHONE NO : 39 335 5300347 
Via Lepanto 84                    SE DECISION MADE: 30-AUG-23
Pompei  IT 80045                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ochsner Connected Inhaler Sensor
Ochsner Clinic Foundation         510(k) NO: K223367(Traditional)
ATTN: Hakm  Murad                 PHONE NO : 504 8427785 
1514 Jefferson Hwy                SE DECISION MADE: 30-AUG-23
New Orleans LA  70121             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Citric Complete Liquid Citric Acid Concentrate
Nipro Renal Solutions USA, Corp.  510(k) NO: K223431(Traditional)
ATTN: Vincent  DeGrandchamp       PHONE NO : 267 6784390 
509 Fishing Creek Road            SE DECISION MADE: 04-AUG-23
Lewisberry PA  17339              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArtiFascia
Nurami Medical Ltd.               510(k) NO: K223445(Traditional)
ATTN: Hannoch  Marksheid          PHONE NO : 972 74 7408822 
Ha'Namal 36                       SE DECISION MADE: 10-AUG-23
Haifa  IL 3303203                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Otsuka Digital Feedback Device-RW
Otsuka America Pharmaceutical, Inc510(k) NO: K223463(Traditional)
ATTN: Nancy  Teague               PHONE NO : 240 6833560___ 
2440 Research Boulevard           SE DECISION MADE: 11-AUG-23
Rockville MD  20850               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexis® compressive screws
Novastep                          510(k) NO: K223468(Abbreviated)
ATTN: Gilles  Audic               PHONE NO : 33 29 9338650 
2, allée Jacques Frimot           SE DECISION MADE: 30-AUG-23
Rennes  FR 350000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V-PRO maX 2 Low Temperature Sterilization System
Steris Corporation                510(k) NO: K223476(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437___ 
5960 Heisley Rd                   SE DECISION MADE: 07-AUG-23
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AQUAbase nX, AQUAbase nX HT
B. Braun Medical Inc.             510(k) NO: K223479(Traditional)
ATTN: Rushtin  Chaklader          PHONE NO : 610 5962789 
901 Marcon Blvd                   SE DECISION MADE: 16-AUG-23
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuperBall Meniscal Repair System
Arcuro Medical Ltd.               510(k) NO: K223500(Traditional)
ATTN: Lee  Ranon                  PHONE NO : 972 72 2607000 
17 Tchelet St.                    SE DECISION MADE: 10-AUG-23
Misgav  IL 2017400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
Good Doctors Co., Ltd.            510(k) NO: K223507(Traditional)
ATTN: Heeseop  Lim                PHONE NO : 714 2025789 
#208, B-Dong, 283 Bupyeong-Daero, SE DECISION MADE: 04-AUG-23
Incheon  KR 21315                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carex Hybrid Personal Lubricant
Karex Industries Sdn. Bhd.        510(k) NO: K223519(Abbreviated)
ATTN: Lai Peng Lim                PHONE NO : 60 7 6881996 
PTD 7906 & 7907, Taman Pontian JaySE DECISION MADE: 11-AUG-23
Pontian  MY 82000                 510(k) STATEMENT
                                                    

DEVICE: ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
Smith & Nephew Medical Limited    510(k) NO: K223526(Traditional)
ATTN: Hannah  Sharp               PHONE NO : 44 077 40531714 
101 Hessle Road                   SE DECISION MADE: 18-AUG-23
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Little Wave Clik, Rogue XP, Little Wave XP, Spark
Ki Mobility LLC                   510(k) NO: K223527(Traditional)
ATTN: Mark  Murphy                PHONE NO : 715 3036447 
5201 Woodward Drive               SE DECISION MADE: 31-AUG-23
Stevens Point WI  54481           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Little Wave Arc; Little Wave Flip
Ki Mobility LLC                   510(k) NO: K223533(Traditional)
ATTN: Mark  Murphy                PHONE NO : 715 3036447 ______
5201 Woodward Drive               SE DECISION MADE: 31-AUG-23
Stevens Point WI  54481           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Integrity Implant
Anika Therapeutics, Inc.          510(k) NO: K223538(Traditional)
ATTN: Wei  Zhao                   PHONE NO : 978 8885948 
32 Wiggins Ave.                   SE DECISION MADE: 17-AUG-23
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dreem 3S
Beacon Biosignals, Inc.           510(k) NO: K223539(Traditional)
ATTN: Delphine  Lemoine           PHONE NO : 33 6 32047992 
22 Boston Wharf Rd., 7th Floor, unSE DECISION MADE: 18-AUG-23
Boston MA  02210                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TubaVent Balloon Dilatation System
Spiggle & Theis Medizintechnik Gmb510(k) NO: K223542(Traditional)
ATTN: Claudia  Winterschladen     PHONE NO : 49 2206 908165 
Burghof 4                         SE DECISION MADE: 03-AUG-23
Overath  DE 51491                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Water for Inhalation in 1L Flexoval ® bottles.
Hometa Inc                        510(k) NO: K223551(Traditional)
ATTN: Raza  Mohammed              PHONE NO : 443 5545486 
300 Great Oaks Blvd, Suite 325    SE DECISION MADE: 03-AUG-23
Albany NY  12203                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Brainlab AG                       510(k) NO: K223553(Traditional)
ATTN: Sadwini  Suresh             PHONE NO : 49 8999 15680 
Olof-Palme-Str.9                  SE DECISION MADE: 02-AUG-23
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Plato 17 Microcatheter
Scientia Vascular Inc             510(k) NO: K223560(Traditional)
ATTN: Max  Alfonso                PHONE NO : 888 3859016 
3487 West 2100 South Suite 100    SE DECISION MADE: 21-AUG-23
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Onera Sleep Test System (Onera STS)
Onera B.V.                        510(k) NO: K223573(Traditional)
ATTN: Ruben de Francisco Martin   PHONE NO : 31 0 403082177 
Torenallee 42-54                  SE DECISION MADE: 18-AUG-23
Eindhoven  NL 5617BD              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
Philips Medizin Systeme Boeblingen510(k) NO: K223574(Traditional)
ATTN: Siegfried  Breitling        PHONE NO : 49 151 20044377 
Hewlett-Packard-Strasse 2         SE DECISION MADE: 22-AUG-23
Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pre-Filled Normal Saline Flush Syringe
Anhui Tianyang Pharmaceutical Co.,510(k) NO: K223584(Traditional)
ATTN: Zhang  Shunlin              PHONE NO : 86 158 05509075 
46 Tiantong Road, Tianchang City, SE DECISION MADE: 12-AUG-23
Tianchang  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Access Folate Assay
Beckman Coulter, Inc.             510(k) NO: K223590(Traditional)
ATTN: Dr. Kuljeet  Kaur           PHONE NO : 1 952 4651914___ 
1000 Lake Hazeline Drive          SE DECISION MADE: 23-AUG-23
Chaska MN  55318                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 23andMe® Personal Genome Service® (PGS®) Cancer Predisposition Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
23andMe, Inc.                     510(k) NO: K223597(Traditional)
ATTN: Marianna  Frendo            PHONE NO : 650 6869288 
349 Oyster Point Blvd             SE DECISION MADE: 31-AUG-23
South San Francisco CA  94080     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterilization Wrap
Wuhan Zonsen Medical Products Co.,510(k) NO: K223600(Traditional)
ATTN: Linna  Ye                   PHONE NO : 
No 8 Jinchao Rd, Zhucheng Street  SE DECISION MADE: 25-AUG-23
Wuhan  CN                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LifeShield™ Infusion Safety Software Suite
ICU Medical, Inc.                 510(k) NO: K223606(Traditional)
ATTN: Pernell  Abrantes           PHONE NO : 224 7062229 
600 N. Field Drive                SE DECISION MADE: 24-AUG-23
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Plum Duo™ Infusion System
ICU Medical, Inc.                 510(k) NO: K223607(Traditional)
ATTN: Yuliya  Matlin              PHONE NO : 224 7062419 
600 N. Field Drive                SE DECISION MADE: 24-AUG-23
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEM Premier 7000 with IQM3
Instrumentation Laboratory Company510(k) NO: K223608(Traditional)
ATTN: Gabriella  Erdosy           PHONE NO : 781 8614571 
180 Hartwell Road                 SE DECISION MADE: 10-AUG-23
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rubicon™ Control Support Catheter (H749394323506A1)
Boston Scientific Corporation     510(k) NO: K223633(Traditional)
ATTN: Mary-Jo  Foley              PHONE NO : 353 0915 17427 
One Scimed Place Maple Grove      SE DECISION MADE: 08-AUG-23
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VisAble.IO
TechsoMed                         510(k) NO: K223639(Traditional)
ATTN: Dalia  Dickman, PhD         PHONE NO : 972 54 5595951 
Meir Weisgal 2                    SE DECISION MADE: 28-AUG-23
Rehovot  IL 7654055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SaintView
Inviz Corporation                 510(k) NO: K223660(Traditional)
ATTN: Priscilla  Chung            PHONE NO : 714 2025789 
307, Biomedical Components Center,SE DECISION MADE: 14-AUG-23
Gwangju  KR                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgeon Controlled Arm
Levita Magnetics International Cor510(k) NO: K223673(Traditional)
ATTN: Alberto  Rodriguez-Navarro, PHONE NO : 650 2410320 
4055-A Campbell Avenue            SE DECISION MADE: 04-AUG-23
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Needle Guides and Grids
Advance Medical Designs, Inc.     510(k) NO: K223689(Traditional)
ATTN: David  Mackie               PHONE NO : 1 770 4223125 244
1241 Atlanta Industrial Drive     SE DECISION MADE: 02-AUG-23
Marietta GA  30066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kyphoplasty Balloon Catheter
Jiangsu Changmei Medtech Co., Ltd.510(k) NO: K223709(Traditional)
ATTN: Yang  Lifan                 PHONE NO : 86 186 51969542 
No.27, Xinke West Road, Luoyang ToSE DECISION MADE: 16-AUG-23
Changzhou  CN 213104              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANNE One
Sibel Health Inc.                 510(k) NO: K223711(Traditional)
ATTN: Sarah  Coughlin             PHONE NO : 224 2518859 
6650 W Touhy Ave.                 SE DECISION MADE: 10-AUG-23
Niles IL  60714                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Better Care Plastic Technology Co.510(k) NO: K223713(Traditional)
ATTN: Zhu  Chunyan                PHONE NO : 86 311 66766067 
Fuqian Xi Road, West district of SSE DECISION MADE: 07-AUG-23
Shenze County  CN 050000          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lavieen
Won Tech Co., Ltd.                510(k) NO: K223727(Traditional)
ATTN: Hyun Sik Yoon               PHONE NO : 82 10 67505346 
64 Techno 8-ro                    SE DECISION MADE: 25-AUG-23
Yuseong-gu  KR 34028              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECGenius System
Cath Vision ApS                   510(k) NO: K223787(Traditional)
ATTN: Mads  Matthiesen            PHONE NO : 45 31 470730 
Titangade 11                      SE DECISION MADE: 04-AUG-23
Copenhagen N  DK 2200             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable Temperature Probe, Disposable Temperature Probe
Shenzhen SINO-K Medical Technology510(k) NO: K223807(Traditional)
ATTN: Lao  Chengxin               PHONE NO : 86 137 15333326 
Room401,Bldg2, Veteran Ind.City,GoSE DECISION MADE: 25-AUG-23
Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aveta System 2.0
Meditrina, Inc.                   510(k) NO: K223813(Traditional)
ATTN: Csaba  Truckai              PHONE NO : 408 4714877 
1190 Saratoga Avenue, Suite 180   SE DECISION MADE: 21-AUG-23
San Jose CA  95129                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Self-Cath Closed System
Coloplast                         510(k) NO: K223821(Traditional)
ATTN: Preeti  Jain                PHONE NO : 612 4135614___ 
1601 West River Road North        SE DECISION MADE: 02-AUG-23
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eRapid Nebulizer System
PARI Respiratory Equipment, Inc.  510(k) NO: K223840(Traditional)
ATTN: Michael  Judge              PHONE NO : 804 2537274 
2412 Pari Way                     SE DECISION MADE: 11-AUG-23
Midlothian VA  23112              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuEra Tight RF Family
BIOS s.r.l.                       510(k) NO: K223856(Traditional)
ATTN: Manuela  Brambilla          PHONE NO : 0039 02 27304275 
Via Guido Rossa 10/12             SE DECISION MADE: 11-AUG-23
Vimodrone  IT 20055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IDS ACTH II
Immunodiagnostic Systems Limited  510(k) NO: K223867(Traditional)
ATTN: Mick  Henderson             PHONE NO : 44 191___ 5190660 
10 Didcot Way,  Boldon Business PaSE DECISION MADE: 18-AUG-23
Boldon  GB NE35 9PD               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BAROguard
Paragonix Technologies            510(k) NO: K223874(Traditional)
ATTN: Nathan  Yetton              PHONE NO : 1 617 8177790 
Suite 408, 639 Granite St.        SE DECISION MADE: 15-AUG-23
Braintree MA  02184               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Daye Tampon
Annes Daye Ltd                    510(k) NO: K223883(Traditional)
ATTN: Valentina  Milanova         PHONE NO : 447 366 456294 
The Biscuit Factory, 100 Drummond SE DECISION MADE: 18-AUG-23
London  GB SE16 4DG               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitalFlowTM Centrifugal Pump
Michigan Critical Care Consultants510(k) NO: K223898(Traditional)
ATTN: Martha  Rumford             PHONE NO : 734 9959089 
2555 Bishop Circle West           SE DECISION MADE: 25-AUG-23
Dexter MI  48130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InterCollagen® Guide
SigmaGraft Inc.                   510(k) NO: K223912(Traditional)
ATTN: Elcin  Chang                PHONE NO : 1 714 5250112 
575 Sally Place                   SE DECISION MADE: 17-AUG-23
Fullerton CA  92831               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMNUM (V.1.1.2.)
Honeynaps Co., Ltd                510(k) NO: K223922(Traditional)
ATTN: Tony  Lee                   PHONE NO : 82 108 9220937 
4F, Marine Tech B/D, 529, NonhyeonSE DECISION MADE: 16-AUG-23
Seoul  KR 06126                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LW Implant System
Ossvis Co., Ltd.                  510(k) NO: K223924(Traditional)
ATTN: Young Jae Kim               PHONE NO : 82 31 3600082 
7F and B1, 38, Burim-ro 170beon-giSE DECISION MADE: 08-AUG-23
Anyang-si  KR 14055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silk'n Titan Allways
Silk'n Beauty Ltd.                510(k) NO: K230013(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 30-AUG-23
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
Tonica Elektronik A/S             510(k) NO: K230014(Traditional)
ATTN: Jan  Kjøller                PHONE NO : 45 2 4899976 
Lucernemarken 15                  SE DECISION MADE: 25-AUG-23
Farum  DK DK-3520                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
Ansell Healthcare Products, LLC.  510(k) NO: K230079(Traditional)
ATTN: Don  Cronk                  PHONE NO : 775 4707106 
2301 Robb Drive                   SE DECISION MADE: 23-AUG-23
Reno NV  89523                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
Responsive Arthroscopy LLC        510(k) NO: K230094(Traditional)
ATTN: Garrett  Ahlborg            PHONE NO : 612 5326800 
701 N. 3rd Street, Suite 208      SE DECISION MADE: 25-AUG-23
Minneapolis MN  55401             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentis s-Clean Regular Abutment
Dentis Co., Ltd                   510(k) NO: K230126(Traditional)
ATTN: Gyu Ri Kim                  PHONE NO : 82 53 5893541 
99, Seongseoseo-ro, Dalseo-gu     SE DECISION MADE: 04-AUG-23
Daegu  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mick Valencia Applicator Set
Mick Radio-Nuclear Instruments, In510(k) NO: K230155(Traditional)
ATTN: James  Hurlman              PHONE NO : 914 6670291 
521 Homestead Avenue              SE DECISION MADE: 30-AUG-23
Mount Vernon NY  10550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SoundBite® Crossing System XS Peripheral
Soundbite Medical Solutions, Inc. 510(k) NO: K230159(Traditional)
ATTN: Diane  Marceau              PHONE NO : 514 9562525 3352
2300 Alfred Nobel, Suite 230      SE DECISION MADE: 28-AUG-23
Montreal  CA H4S 2A4              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare510(k) NO: K230162(Traditional)
ATTN: Xin  Gao                    PHONE NO : 86 21670 768885386 
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 01-AUG-23
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé  (20101 Male CH10 - large packaging), Luja Coudé  (20102 Male CH12 - large packaging), Luja Coudé  (20104 Male CH14 - large packaging), Luja Coudé  (20106 Male CH16 - large packaging)
Coloplast                         510(k) NO: K230165(Traditional)
ATTN: Troy  Thome                 PHONE NO : 612 3569917 
1601 West River Road North        SE DECISION MADE: 25-AUG-23
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter
Beijing Choice Electronic Technolo510(k) NO: K230172(Traditional)
ATTN: Haiying  Zhao               PHONE NO : 86 10 88794631 
No. 9 Shuangyuan road, Badachu Hi-SE DECISION MADE: 12-AUG-23
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
Versant Medical Physics and Radiat510(k) NO: K230221(Traditional)
ATTN: Darrell R. Fisher           PHONE NO : 509 5393223___ 
119 N. Church Street              SE DECISION MADE: 28-AUG-23
Kalamazoo MI  49007               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZenPro 40
Bluecore Company Co Ltd           510(k) NO: K230268(Traditional)
ATTN: Bill  Choi                  PHONE NO : 82 517 474318 
Ace Hightech 21 #1203 48, Centurm SE DECISION MADE: 10-AUG-23
Busan  KR 48059                   510(k) STATEMENT
                                                    

DEVICE: PMT Expandable Cage (PMT EXP)
Providence Medical Technology, Inc510(k) NO: K230297(Traditional)
ATTN: Edward  Liou                PHONE NO : 415 9239376 
4234 Hacienda Drive, Suite 150    SE DECISION MADE: 11-AUG-23
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celsi Monitor
Hadleigh Health Technologies      510(k) NO: K230298(Traditional)
ATTN: Molly  McCabe               PHONE NO : 510 6733653 
30 Castro Avenue                  SE DECISION MADE: 16-AUG-23
San Rafael CA  94901              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polyisoprene Surgical Gloves
Puyang Linshi Medical Supplies Co.510(k) NO: K230304(Traditional)
ATTN: Catherine  Liu              PHONE NO : 86 198 39327898 
East of Panjin Road and North of FSE DECISION MADE: 09-AUG-23
Puyang  CN 457001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
New Era Medicare Sdn. Bhd.        510(k) NO: K230314(Traditional)
ATTN: Fatin Nor Irdina binti AhmadPHONE NO : 60 149 072860 
Plot 2621-2624                    SE DECISION MADE: 16-AUG-23
Teluk Intan  MY 36000             510(k) STATEMENT
                                                    

DEVICE: Phototherapy System  (OL-PDT950)
Shanghai Omni Laser Skinology Co.,510(k) NO: K230342(Traditional)
ATTN: Avril  Ouyang               PHONE NO : 86 021 54847192 
Floor 3, Building 3, NO.227, MingqSE DECISION MADE: 16-AUG-23
Shanghai  CN 201612               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K230355(Traditional)
ATTN: Janine F Reyes              PHONE NO : 714 6697853 
1385 Shimoshigami                 SE DECISION MADE: 30-AUG-23
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitalFlow™ Console
Michigan Critical Care Consultants510(k) NO: K230364(Traditional)
ATTN: Martha  Rumford             PHONE NO : 734 9959089 
2555 Bishop Circle West           SE DECISION MADE: 25-AUG-23
Dexter MI  48130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Agilis NxT Steerable Introducer
Innovative Health, LLC.           510(k) NO: K230376(Traditional)
ATTN: Rick  Ferreira              PHONE NO : 877 4003740 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 07-AUG-23
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Masks, Model: EFMDS-L50Pn BLU
Iris USA                          510(k) NO: K230380(Traditional)
ATTN: Michael  Cruz               PHONE NO : 602 7071770 
11111 80th Ave.                   SE DECISION MADE: 03-AUG-23
Pleasant Prairie WI  53158        510(k) STATEMENT
                                                    

DEVICE: PolyWear® Personal Protective Level 3 Gown
Polyconversions, INC              510(k) NO: K230384(Traditional)
ATTN: William  Smith              PHONE NO : 309 6623614 
3202 Apollo Drive                 SE DECISION MADE: 11-AUG-23
Champaign IL  61822               510(k) STATEMENT
                                                    

DEVICE: Wrist Type Blood Pressure Monitor (W05,W1101L)
Shenzhen Jamr Technology Co., Ltd.510(k) NO: K230409(Traditional)
ATTN: Haiyu  Zhang                PHONE NO : 86 186 75539961 
A101-301, D101-201, Jamr Science &SE DECISION MADE: 25-AUG-23
Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cadwell Guardian
Cadwell Industries, Inc.          510(k) NO: K230415(Traditional)
ATTN: Jason  Ford                 PHONE NO : 509 7356481 
909 North Kellogg Street          SE DECISION MADE: 17-AUG-23
Kennewick WA  99336               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sequel Tampon with Plastic Applicator
Tampro Inc                        510(k) NO: K230419(Traditional)
ATTN: Greta  Meyer                PHONE NO : 215 2609081 
3749 Buchanan Street #316         SE DECISION MADE: 03-AUG-23
San Fransisco CA  94123           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dr. pen Microneedling System
Guangzhou Ekai Electronic Technolo510(k) NO: K230420(Traditional)
ATTN: Guihua  Chen                PHONE NO : 86 020 81177539 
3/F Building E No.81 Zijing Road, SE DECISION MADE: 11-AUG-23
Guangzhou  CN 510000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
Ambu A/S                          510(k) NO: K230428(Traditional)
ATTN: Karina  Matthiesen          PHONE NO : 45 7225 2094 
Baltorpbakken 13                  SE DECISION MADE: 10-AUG-23
Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Syringe Bulk Tray
Shanghai Kindly Enterprise Develop510(k) NO: K230447(Traditional)
ATTN: Hualong  Liu                PHONE NO : 86 02169 118232 
No.658 Gaochao Road               SE DECISION MADE: 16-AUG-23
Shanghai  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cove Strip
SeaSpine Orthopedics Corporation  510(k) NO: K230486(Traditional)
ATTN: Cindy  Toyama               PHONE NO : 949 8557175 
2 Goodyear                        SE DECISION MADE: 21-AUG-23
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EL27-Compact; Sterile EHL-Probes
Walz Elektronik GmbH              510(k) NO: K230488(Traditional)
ATTN: Bernd  Vollmer              PHONE NO : 49 745 22020 
Walddorfer Strasse 40             SE DECISION MADE: 31-AUG-23
Rohrdorf  DE 72229                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visual-ICE Cryoablation System
Boston Scientific Corporation     510(k) NO: K230551(Traditional)
ATTN: Amy  McKinney               PHONE NO : 651 2875096 
One Scimed Place                  SE DECISION MADE: 08-AUG-23
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co.,Ltd        510(k) NO: K230566(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
No.365, Wuzhou Road Yuhang EconomiSE DECISION MADE: 25-AUG-23
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
Medcare Saglik Urunleri Sanayi Ve 510(k) NO: K230577(Traditional)
ATTN: Muge  Ersahin               PHONE NO : 90 232 28116 
Fatih Mah. Camlik Cad No 54       SE DECISION MADE: 16-AUG-23
Izmir  TR 35410                   510(k) STATEMENT
                                                    

DEVICE: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
WRP Asia Pacific Sdn. Bhd.        510(k) NO: K230578(Traditional)
ATTN: Saravanan  Ramasamy         PHONE NO : 60 387 061486 
Lot 1, Jalan 3, Kawasan PerusahaanSE DECISION MADE: 31-AUG-23
Sepang  MY 43900                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart Wedge algorithm
Edwards Lifesciences, LLC         510(k) NO: K230579(Traditional)
ATTN: Jennifer  Wilbur            PHONE NO : 949 7564436 
1 Edwards Way                     SE DECISION MADE: 18-AUG-23
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TOPA12 Portable X-ray Unit
NEUF Inc.                         510(k) NO: K230581(Traditional)
ATTN: Woo Sang Lee                PHONE NO : 82 61 7402830 
#103 Production Bldg. 13, YulchonsSE DECISION MADE: 16-AUG-23
Suncheon-si  KR 58034             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aer-O-Scope Colonoscope System
GI View Ltd.                      510(k) NO: K230588(Traditional)
ATTN: Sharon  Goldfarb            PHONE NO : 972 54 6454034 
5 Shoham St.                      SE DECISION MADE: 17-AUG-23
Ramat Gan  IL 5251001             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
Teleflex Medical                  510(k) NO: K230603(Traditional)
ATTN: Kristen  Bisanz             PHONE NO : 404 2909807 
3015 Carrington Mill Blvd.        SE DECISION MADE: 30-AUG-23
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPICCA Cervical Fusion Cages
Southern Medical (Pty) Ltd        510(k) NO: K230607(Traditional)
ATTN: Nathan  Wright              PHONE NO : 719 3510248 
Building 10, Southern Implants OffSE DECISION MADE: 14-AUG-23
Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPICCA Stand-Alone Cervical Fusion Cages
Southern Medical (Pty) Ltd        510(k) NO: K230608(Traditional)
ATTN: Dalene  Styger              PHONE NO : 27 12 6676243 
55 Regency Drive Route 21 CorporatSE DECISION MADE: 14-AUG-23
Irene  ZA 0178                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
Dongguan Shin Yi Healthcare Produc510(k) NO: K230610(Traditional)
ATTN: Shuge  Zhao                 PHONE NO : 86 769 8336138 
No. 17 Ban Hu Road, Huang Jiang ToSE DECISION MADE: 23-AUG-23
Dong Guan  CN 523750              510(k) STATEMENT
                                                    

DEVICE: SKEEPER
Smartsound Corporation            510(k) NO: K230613(Traditional)
ATTN: Jungho  Lee                 PHONE NO : 82 257 52252 
171, Yangjaecheon-ro, Gangnam-gu  SE DECISION MADE: 02-AUG-23
Seoul  KR 06302                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
Gentuity, LLC                     510(k) NO: K230620(Traditional)
ATTN: Padmini  Gagnon             PHONE NO : 508 4251560 
142 North Road, Suite G           SE DECISION MADE: 08-AUG-23
Sudbury MA  01776                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReliOn Premier BLU Blood Glucose Monitoring System
i-SENS, Inc.                      510(k) NO: K230625(Special)
ATTN: H.S.  Yoo                   PHONE NO : 82 29 100516 
43, Banpo-Daero 28 Gil Seocho-Gu  SE DECISION MADE: 10-AUG-23
Seoul  KR 06646                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01); Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01), Portrait™ RR Electrode Patch (Portrait RRP01)
GE Medical Systems Information Tec510(k) NO: K230626(Traditional)
ATTN: Joel  Kent                  PHONE NO : 617 8510943 
9900 Innovation Drive             SE DECISION MADE: 11-AUG-23
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersiHD with GuideMe software
NxStage Medical, Inc.             510(k) NO: K230632(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 9969103 
350 Merrimack St.                 SE DECISION MADE: 11-AUG-23
Lawrence MA  01843                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Blood Pressure Monitor
Dongguan kangweile Electronic Tech510(k) NO: K230642(Traditional)
ATTN: Zhixin  Gao                 PHONE NO : 86 769 82677482 
4th floor, building D, Yizhong SciSE DECISION MADE: 11-AUG-23
Dongguan  CN 523770               510(k) STATEMENT
                                                    

DEVICE: Density
Jeisys Medical Inc.               510(k) NO: K230663(Traditional)
ATTN: Bora  Kim                   PHONE NO : 82 10 30197221 
307 Daeryung Techno Town 8th      SE DECISION MADE: 14-AUG-23
Seoul  KR 08501                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Annabella Breast Pump
Annabella Ltd.                    510(k) NO: K230672(Traditional)
ATTN: Uri  Yaffe                  PHONE NO : 97 254 5555484 
23/5 Hataas                       SE DECISION MADE: 04-AUG-23
KFAR SABA  IL 4442525             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tandry Locking Plate System
Microware Precision Co., Ltd.     510(k) NO: K230690(Traditional)
ATTN: Harrison  Du                PHONE NO : 886 4 24636275 100
No. 12, Keyuan 2nd Rd., Situn DistSE DECISION MADE: 17-AUG-23
Taichung  TW 40763                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Resorbable Fixation System
Stryker Leibinger GmbH & Co. KG   510(k) NO: K230733(Traditional)
ATTN: Gregory  Gohl               PHONE NO : 269 3701476 
Boetzinger Strasse 41             SE DECISION MADE: 05-AUG-23
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Ureteral Access Sheath
YouCare Technology Co., Ltd. (Wuha510(k) NO: K230748(Traditional)
ATTN: Bing  Hu                    PHONE NO : 86 27 87926396 830___
Tangxunhu North Street            SE DECISION MADE: 02-AUG-23
Wuhan  CN 430000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TK Pre-Filled Normal Saline Flush Syringe
Anhui Tiankang Medical Technology 510(k) NO: K230756(Traditional)
ATTN: Bai  Baodong                PHONE NO : 86 1350 5557811 
No. 228 Weiyi Road, Economic DevelSE DECISION MADE: 12-AUG-23
Tianchang  CN                     510(k) STATEMENT
                                                    

DEVICE: Precice Ankle Salvage System
NuVasive Specialized Orthopedics, 510(k) NO: K230765(Traditional)
ATTN: Miriam  Cervantes           PHONE NO : 909 2297836 
101 Enterprise, Suite 100         SE DECISION MADE: 29-AUG-23
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Withings Scan Monitor 2.0
Withings                          510(k) NO: K230812(Traditional)
ATTN: Khushboo  Surendran         PHONE NO : 857 2052072 
2 rue Maurice Hartmann            SE DECISION MADE: 23-AUG-23
Issy-Les-Moulineaux  FR 92130     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powdered Free Sterile Natural Rubber Latex Surgical Gloves
The Egyptian Company For Medical &510(k) NO: K230832(Traditional)
ATTN: Alaa  Elsayed               PHONE NO : 201 0000 80163 
Industrial Zone 7. Part 7062A&B   SE DECISION MADE: 16-AUG-23
Sadat City  EG                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXTRON 5; EXTRON 7
DRTECH Corporation                510(k) NO: K230871(Traditional)
ATTN: Kim  Minjeong               PHONE NO : 82 031 7797783 
Suite No. 1, 2 Floor/Suite No. 2, SE DECISION MADE: 17-AUG-23
Seongnam-si  KR 13216             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
Southern Implants (Pty) Ltd       510(k) NO: K230873(Traditional)
ATTN: Colin  Saffy                PHONE NO : 27 12 6671046 
1 Albert Road                     SE DECISION MADE: 01-AUG-23
Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: qXR-PTX-PE
Qure.ai Technologies              510(k) NO: K230899(Traditional)
ATTN: Ayushi  Mahendra            PHONE NO : 91 22 68505800 
Level 7, Commerz II, InternationalSE DECISION MADE: 22-AUG-23
Mumbai  IN 400063                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
Vein 360 LLC                      510(k) NO: K230928(Traditional)
ATTN: Suzanne  Meyer              PHONE NO : 513 5541300 
4460 Lake Forest Dr Suite 230     SE DECISION MADE: 25-AUG-23
Blue Ash OH  452423741            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Radiopaque FiberTape Cerclage sutures
Arthrex, Inc                      510(k) NO: K230976(Traditional)
ATTN: Stacy  Valdez               PHONE NO : 1 239 6435553 72010
1370 Creekside Boulevard          SE DECISION MADE: 24-AUG-23
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yomi Robotic System
Neocis Inc.                       510(k) NO: K231018(Traditional)
ATTN: Joshua  Davis               PHONE NO : 508 2940749 
2800 Biscayne Blvd Suite 600      SE DECISION MADE: 14-AUG-23
Miami FL  33137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AquaBeam Robotic System
PROCEPT BioRobotics Corporation   510(k) NO: K231024(Traditional)
ATTN: Sara  Muddell               PHONE NO : 650 2327217 
900 Island Drive, Suite 101       SE DECISION MADE: 30-AUG-23
Redwood City CA  94065            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 12MP Color LCD Monitor C1216W, C12*** ("*" = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
Shenzhen Beacon Display Technology510(k) NO: K231026(Traditional)
ATTN: Li  Yafei                   PHONE NO : 86 248 8087610 
15F, Building 6, Hengda Shishang HSE DECISION MADE: 18-AUG-23
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unicare (K-UNICARE-USA)
TensCare Ltd                      510(k) NO: K231053(Traditional)
ATTN: Saskia  Eldridge-Hinmers    PHONE NO : 44 137 2723434 
9 Blenheim Road                   SE DECISION MADE: 18-AUG-23
Epsom  GB KT199BE                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V-Laser
WON TECH Co., Ltd.                510(k) NO: K231054(Special)
ATTN: Hyun Sik Yoon               PHONE NO : 82 10 67505346 
64 Techno 8-ro, Yuseong-gu        SE DECISION MADE: 14-AUG-23
Daejeon  KR 34028                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1.5T HD T/R Knee Array (10-F34127)
Shenzhen RF Tech Co., Ltd.        510(k) NO: K231085(Traditional)
ATTN: Wang  Gary                  PHONE NO : 0086__ 7552 6641989 
2-F,BLD4 Juhui Industrial Park,TiaSE DECISION MADE: 18-AUG-23
Shenzhen  CN 518132               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guided Surgery Kit
Implant Direct Sybron Manufacturin510(k) NO: K231087(Traditional)
ATTN: Reina  Choi                 PHONE NO : 1 818 3073132 
3050 East Hillcrest Drive         SE DECISION MADE: 16-AUG-23
Thousand Oaks CA  91362           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlphaVent Suture Anchors
Stryker Endoscopy                 510(k) NO: K231093(Traditional)
ATTN: Katie  Farraro              PHONE NO : 408___ 4647396 
5900 Optical Ct.                  SE DECISION MADE: 30-AUG-23
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Annalise Enterprise CTB Triage-OH
Annalise-AI Pty Ltd               510(k) NO: K231094(Traditional)
ATTN: Haylee  Bosshard            PHONE NO : 61 4932 66602 
Level P, 24 Campbell St.          SE DECISION MADE: 15-AUG-23
Sydney  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automatic Continuous Effusion Shunt (ACES) System ACES System
Pleural Dynamics, Inc.            510(k) NO: K231096(Traditional)
ATTN: Martin  Mayse               PHONE NO : 314 5181786 
952 Medina Road                   SE DECISION MADE: 18-AUG-23
Wayzata MN  55391                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LineSider® Spinal System
Integrity Implants Inc.           510(k) NO: K231098(Traditional)
ATTN: Alexa  Kamer                PHONE NO : 561 5293861 
354 Hiatt Drive                   SE DECISION MADE: 07-AUG-23
Palm Beach Gardens FL  33418      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System
Zimmer Switzerland Manufacturing G510(k) NO: K231114(Traditional)
ATTN: Annemie Kausch Rehor        PHONE NO : 41 795 615986 
Sulzerallee 8                     SE DECISION MADE: 09-AUG-23
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
Phoenix Innovative Healthcare Manu510(k) NO: K231123(Traditional)
ATTN: Michael  Stuart             PHONE NO : 954 8804274 
EL-209, Shil Mahape Road ElectroniSE DECISION MADE: 30-AUG-23
Navi Mumbai  IN 400710            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eblator Device
E Surgical, LLC                   510(k) NO: K231126(Traditional)
ATTN: Michael  Blomeyer           PHONE NO : 775___ 4331808___ 
150 Isidor Court Unit 203         SE DECISION MADE: 02-AUG-23
Sparks NV  89441                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Enzyme Packed Cartridge - RELiZORB
Alcresta Therapeutics, Inc.       510(k) NO: K231156(Traditional)
ATTN: Matthew  King               PHONE NO : 603 4599755 
130 Turner Street, Building 3, SuiSE DECISION MADE: 30-AUG-23
Waltham MA  02453                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Conductive carbon film electrode
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K231164(Traditional)
ATTN: Sammy  Li                   PHONE NO : 86 020 34822409 
No.23 Building, The Second Phase, SE DECISION MADE: 09-AUG-23
Guangzhou  CN 511450              510(k) STATEMENT
                                                    

DEVICE: Conductive Silicone Rubber Electrode
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K231167(Traditional)
ATTN: Sammy  Li                   PHONE NO : 86 020 34822409 
No.23 Building, The Second Phase HSE DECISION MADE: 09-AUG-23
Guangzhou  CN 511450              510(k) STATEMENT
                                                    

DEVICE: BPBIO750
InBody Co, Ltd.                   510(k) NO: K231174(Traditional)
ATTN: Kichul  Cha                 PHONE NO : 82 02 5013939 
15, Heugam-Gil , Ipjang-Myueon, SeSE DECISION MADE: 02-AUG-23
Cheonan-Si  KR 31025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non absorbable Surgical Polyester Suture
Shandong Haidike Medical Products 510(k) NO: K231183(Traditional)
ATTN: Yan  Wang                   PHONE NO : 86 530 4660062 
Tianfu Road, Dongcheng District, SSE DECISION MADE: 25-AUG-23
Heze  CN 274300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App
Cochlear                          510(k) NO: K231204(Traditional)
ATTN: Denis  DiMartino            PHONE NO : 508 3044356 
10350 Park Meadows Drive          SE DECISION MADE: 18-AUG-23
Lone Tree CO  80124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
GuruNanda LLC                     510(k) NO: K231205(Traditional)
ATTN: Puneet  Nanda               PHONE NO : 714 4100466 
6645 Caballero Blvd.              SE DECISION MADE: 22-AUG-23
Buena Park CA  90620              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Resorbable Fixation System
Stryker Leibinger GmbH & Co. KG   510(k) NO: K231208(Traditional)
ATTN: Gregory  Gohl               PHONE NO : 269 3701476 
Boetzinger Strasse 41 D-79111     SE DECISION MADE: 14-AUG-23
Freiburg  DE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ventrax™ Delivery System  (VTR851)
Merit Medical Systems, Inc.       510(k) NO: K231246(Traditional)
ATTN: Jenny  Soderquist           PHONE NO : 801 2084579 
1600 West Merit Parkway           SE DECISION MADE: 30-AUG-23
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovoFine® Plus
Novo Nordisk Inc.                 510(k) NO: K231255(Special)
ATTN: Hiral Palkhiwala Shah       PHONE NO : 609 7877603 
P.O Box 846                       SE DECISION MADE: 25-AUG-23
Plainsboro NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pangea Utility Plating System, Pangea Platform
Stryker GmbH                      510(k) NO: K231257(Traditional)
ATTN: Danese  Joiner-Fox          PHONE NO : 475 3334452 
325 Corporate Drive               SE DECISION MADE: 18-AUG-23
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
Stryker GmbH                      510(k) NO: K231262(Traditional)
ATTN: Danese  Joiner-Fox          PHONE NO : 475 3334452 
325 Corporate Drive               SE DECISION MADE: 18-AUG-23
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pediatric Nailing Platform | Tibia
OrthoPediatrics Corp.             510(k) NO: K231266(Traditional)
ATTN: Yan  Li                     PHONE NO : 574 2670864 
2850 Frontier Drive               SE DECISION MADE: 21-AUG-23
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Natural Cycles
Natural Cycles Nordic AB          510(k) NO: K231274(Traditional)
ATTN: Raoul  Scherwitzl, PhD      PHONE NO : 46 707 174866____ 
St Eriksgatan 63b                 SE DECISION MADE: 24-AUG-23
Stockholm  SE 112 34              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartCardia 7L Platform
SmartCardia SA                    510(k) NO: K231276(Traditional)
ATTN: Srinivasan  Murali          PHONE NO : 41 788 750864 
EPFL Innovation Park Building C   SE DECISION MADE: 30-AUG-23
Lausanne  CH 1015                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Knotless Suture Anchor
Riverpoint Medical, LLC           510(k) NO: K231278(Traditional)
ATTN: Bianca Silva de Sousa       PHONE NO : 503 5178001 
815 NE 25th Ave                   SE DECISION MADE: 01-AUG-23
Portland OR  97232                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Chemfort® Catheter Adaptor
Simplivia Healthcare LTD.         510(k) NO: K231286(Traditional)
ATTN: Shay  Shaham                PHONE NO : 97 246 908826 
North Industrial Zone             SE DECISION MADE: 02-AUG-23
Kiryat Shmona  IL 1101801         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S-Patch Ex Wearable ECG Patch
Wellysis Corp.                    510(k) NO: K231289(Traditional)
ATTN: DoGyun  Im                  PHONE NO : 82 109 1408475 
8F, 425 Teheran-ro, Gangnam-gu    SE DECISION MADE: 30-AUG-23
Seoul  KR 06159                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vscan Air
GE Medical Systems Ultrasound and 510(k) NO: K231301(Traditional)
ATTN: Bush  Lee                   PHONE NO : 262 3099429 
9900 W. Innovation Drive          SE DECISION MADE: 15-AUG-23
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ancora-SB
Aspero Medical, Inc.              510(k) NO: K231323(Traditional)
ATTN: Mark  Rentschler            PHONE NO : 303 8347885 
320 E. Vine Drive, Suite 101      SE DECISION MADE: 31-AUG-23
Fort Collins CO  80524            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUX-Dx II (M302); LUX-Dx II+ (M312)
Boston Scientific Corp            510(k) NO: K231328(Traditional)
ATTN: Melissa  Klamerus           PHONE NO : 651 5826771 
4100 Hamline Ave North            SE DECISION MADE: 19-AUG-23
St. Paul MN  55112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STRETTO™ Cable System
Globus Medical Inc.               510(k) NO: K231333(Traditional)
ATTN: Jennifer  Antonacci         PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 04-AUG-23
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Organic cotton tampon, Viscose tampon
Zhejiang Tianqing Manufacturing Te510(k) NO: K231341(Traditional)
ATTN: Roy  Du                     PHONE NO : 86 138 17862379 
Lianshi Industrial Park, Nanxun DiSE DECISION MADE: 14-AUG-23
Huzhou  CN 313013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ActivSight Intraoperative Imaging System
Activ Surgical Inc.               510(k) NO: K231344(Traditional)
ATTN: Nicholas  Child             PHONE NO : 857 4494840 
30 Thomson Place                  SE DECISION MADE: 02-AUG-23
Boston MA  02110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dewin Blastocyst Medium (with HSA and without HSA)
DonneVie Medical Technology (Shang510(k) NO: K231370(Traditional)
ATTN: Hannah Hang Yin             PHONE NO : 
Suite 201, Bld 1, 138 Xinjun Ring SE DECISION MADE: 04-AUG-23
Shanghai  CN 201114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)
Smith & Nephew Inc.               510(k) NO: K231376(Traditional)
ATTN: Pragnya  Bakka              PHONE NO : 512 3913900 
150 Minuteman Road                SE DECISION MADE: 09-AUG-23
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirLife DuoTherm™ Humidification System
Vyaire Medical, Inc.              510(k) NO: K231380(Traditional)
ATTN: Megan  Walsh                PHONE NO : 872 2063142 
26125 N. Riverwoods Blvd.         SE DECISION MADE: 10-AUG-23
Mettawa IL  60045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Harvest Dental HD Gum Strip
Harvest Dental Products, LLC      510(k) NO: K231389(Traditional)
ATTN: Colleen  Boswell            PHONE NO : 714 5853431 
905 Columbia Street               SE DECISION MADE: 16-AUG-23
Brea CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intense Pulsed Light System
Smedtrum Medical Technology Co., L510(k) NO: K231394(Traditional)
ATTN: Crimson  Wu                 PHONE NO : 88 622 2989578 301
1F., No. 8, Ln. 97, Wugong Rd.,   SE DECISION MADE: 09-AUG-23
New Taipei City  TW 248016        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bladeless Trocar – Artemis Lap Cannula
T.A.G. Medical Products Corporatio510(k) NO: K231400(Special)
ATTN: Shlomi  Dines               PHONE NO : 972 4 9858400 
T.A.G. Medical Products CorporatioSE DECISION MADE: 04-AUG-23
Gaaton  IL 2513000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
Healthium Medtech Limited         510(k) NO: K231404(Traditional)
ATTN: Pankaj  Dawar               PHONE NO : 91 988 6529934 
472-D, 13th Cross, 4th Phase, PeenSE DECISION MADE: 04-AUG-23
Bangalore  IN 560058              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StarFin
Premium Medical Technology LLC    510(k) NO: K231407(Traditional)
ATTN: Kuowei  Chang               PHONE NO : 781 8914201 
1377 Main Street 2nd Floor        SE DECISION MADE: 29-AUG-23
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
Shandong Intco Medical Products Co510(k) NO: K231408(Traditional)
ATTN: Max  Li                     PHONE NO : 86 189 18364816 
No. 9888 Qiwang Road, Naoshan InduSE DECISION MADE: 11-AUG-23
Qingzhou  CN 2625000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erchonia FX-405
Erchonia Corporation              510(k) NO: K231409(Traditional)
ATTN: Travis  Sammons             PHONE NO : 888 2420571 
650 Atlantis Road                 SE DECISION MADE: 11-AUG-23
Melbourne FL  32904               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnSite™ X EP System
Abbott Medical                    510(k) NO: K231415(Traditional)
ATTN: Alyssa  Timmers             PHONE NO : 651 7563706 
One St. Jude Medical Drive        SE DECISION MADE: 10-AUG-23
St. Paul MN  55117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENDOGATOR™ Hybrid Irrigation Tubing
Medivators                        510(k) NO: K231418(Traditional)
ATTN: Disha  Kabrawala            PHONE NO : 732 3197766 
14605 28th Avenue North           SE DECISION MADE: 14-AUG-23
Minneapolis MN  55447             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aura 10 PET/CT
XEOS Medical                      510(k) NO: K231420(Traditional)
ATTN: Bjorn  Delbeecke            PHONE NO : 0032 09 2777794 
Ottergemsesteenweg-Zuid 808 Bus 35SE DECISION MADE: 10-AUG-23
Gent  BE 9000                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precision GI
Limaca Medical Ltd                510(k) NO: K231422(Traditional)
ATTN: Assaf  Klein                PHONE NO : 972 54 2299572 
3 Ha'Rimon street Mevo-Carmel ScieSE DECISION MADE: 28-AUG-23
En Ha'Emeq  IL 1925000            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
Thermo Fisher Scientific          510(k) NO: K231433(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 87189093 224117
1 Thermo Fisher Way               SE DECISION MADE: 31-AUG-23
Oakwood Village OH  44146         510(k) STATEMENT
                                                    

DEVICE: DESS Dental Smart Solutions
Terrats Medical SL                510(k) NO: K231434(Traditional)
ATTN: Roger  Terrats              PHONE NO : 34 935 646006 
Carrer Mogoda 75-99               SE DECISION MADE: 14-AUG-23
Barbera del Valles  ES 08210      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Kimberly-Clark Corporation        510(k) NO: K231435(Traditional)
ATTN: Kimberly  Tempas            PHONE NO : 920 7214084 
1400 Holcomb Bridge Road          SE DECISION MADE: 28-AUG-23
Roswell GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free White, Black, and Purple Nitrile Examination Glove
S&S Glove Corporation             510(k) NO: K231439(Traditional)
ATTN: Poppy Farrah Rossa          PHONE NO : 84 283 8725999 
Lot 4, D6 Road, Dat Do I IndustriaSE DECISION MADE: 11-AUG-23
Ba Ria-Vung Tau  VN VN790000      510(k) STATEMENT
                                                    

DEVICE: Implant-One System
Implant Logistics, Inc.           510(k) NO: K231455(Traditional)
ATTN: Thomas  Arendt              PHONE NO : 1 608 4984855 
711 Spartan Drive                 SE DECISION MADE: 15-AUG-23
Sparta WI  54656                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPARK Scan
SPARK Neuro Inc.                  510(k) NO: K231457(Traditional)
ATTN: Marinela  Gombosev          PHONE NO : 949 5847331 
212 West 18th Street, Unit 17A    SE DECISION MADE: 18-AUG-23
New York NY  10011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Extremity Staple
restor3d                          510(k) NO: K231458(Traditional)
ATTN: Anika  Moorjani             PHONE NO : 501 2403476 
311 West Corporation Street       SE DECISION MADE: 03-AUG-23
Durham NC  27701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Xpress CoV-2/Flu/RSV plus
Cepheid®                          510(k) NO: K231481(Traditional)
ATTN: Suzette  Chance             PHONE NO : 262 6231775 
904 Caribbean Drive               SE DECISION MADE: 17-AUG-23
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celerity™ HP Chemical Indicator;  Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape
STERIS                            510(k) NO: K231488(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Rd                   SE DECISION MADE: 07-AUG-23
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
STERIS Corporation                510(k) NO: K231490(Traditional)
ATTN: Gregory  Land               PHONE NO : 440 3927424 
5960 Heisley Rd                   SE DECISION MADE: 07-AUG-23
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TA™ Stapler and Loading Unit with DST Series™ Technology
Covidien                          510(k) NO: K231491(Traditional)
ATTN: Emily  Jacobs               PHONE NO : 860 9336557 
60 Middletown Ave.                SE DECISION MADE: 16-AUG-23
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NITINEX Memory Compression Staple
Vilex, LLC                        510(k) NO: K231493(Traditional)
ATTN: Brock  Johnson              PHONE NO : 801 9164157 
111 Moffitt Street                SE DECISION MADE: 11-AUG-23
McMinnville TN  37110             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TITAN 3-D Wedge System
Paragon 28 Inc                    510(k) NO: K231496(Traditional)
ATTN: Haylie  Hertz               PHONE NO : 303 7200017 
14445 Grasslands Drive            SE DECISION MADE: 22-AUG-23
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vis-U-All Low Temperature Sterilization Pouches
Steris Corporation                510(k) NO: K231500(Traditional)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 07-AUG-23
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRO-LITE Sterilization Tray
STERIS Corporation                510(k) NO: K231501(Traditional)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 07-AUG-23
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUPTIMIZE™ Advanced
DePuy Orthopaedics, Inc           510(k) NO: K231503(Traditional)
ATTN: Sierra  Robinson            PHONE NO : 850 2519921 
700 Orthopaedic Dr                SE DECISION MADE: 22-AUG-23
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Current Health System
Current Health Ltd                510(k) NO: K231506(Special)
ATTN: Giovanni  Maggi             PHONE NO : 44 131 2858101 
The Stamp Office, Level 3, 10 WateSE DECISION MADE: 24-AUG-23
Edinburgh  GB EH1 3EG             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
Xiantao Zhibo Non-Woven Products C510(k) NO: K231510(Traditional)
ATTN: Fen  Peng                   PHONE NO : 86 188 72609993 
No. 8 Hefeng Industrial Park, PengSE DECISION MADE: 22-AUG-23
Xiantao  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS Immunodiagnostic Products CEA Reagent Pack
Ortho Clinical Diagnostics        510(k) NO: K231517(Traditional)
ATTN: Rebecca  Lewis              PHONE NO : 440 7917 427649 
Felindre Meadows Pencoed          SE DECISION MADE: 23-AUG-23
Bridgend  GB CF35 5PZ             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
Ortho Clinical Diagnostics        510(k) NO: K231525(Traditional)
ATTN: Declan  Hynes               PHONE NO : 44 0750 5370257 
Felindre Meadows Pencoed          SE DECISION MADE: 09-AUG-23
Bridgend  GB CF35 5PZ             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SofWave System
Sofwave Medical Ltd.              510(k) NO: K231537(Traditional)
ATTN: Ruthie  Amir, MD            PHONE NO : 97 254 3003164 
1 Ha-Otsma St.                    SE DECISION MADE: 28-AUG-23
Yokneam Ilit  IL 2069200          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Meical Diode Laser, Model S1Pro
Wuhan Pioon Technology Co., Ltd.  510(k) NO: K231548(Traditional)
ATTN: Feng  Zhang                 PHONE NO : 86 180 62448535 
7th Floor, A21 of Sino Pharm BuildSE DECISION MADE: 03-AUG-23
Wuhan  CN 430075                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZENEX FreeMilling & CCM Cast Abutment
Izenimplant Co., Ltd.             510(k) NO: K231557(Traditional)
ATTN: Ji-Hwan  Jeong              PHONE NO : 82 31 6620657 
1, 2Dong, 26-32, Suworam 4-Gil, SeSE DECISION MADE: 24-AUG-23
Pyeongtaek-Si  KR 17703           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
Medtronic Xomed, Inc.             510(k) NO: K231580(Traditional)
ATTN: Alexandra  Oliver           PHONE NO : 904 3328936 
6743 Southpoint Drive North       SE DECISION MADE: 30-AUG-23
Jacksonville FL  32216            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Route 92 Medical Full Length 054 Access System
Route 92 Medical, Inc.            510(k) NO: K231583(Special)
ATTN: Kirsten  Valley             PHONE NO : 650 2798427 
155 Bovet Road, Suite 100         SE DECISION MADE: 15-AUG-23
San Mateo CA  94402               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire X3 Anterior Cervical Plate System
Spinal Elements, Inc              510(k) NO: K231593(Traditional)
ATTN: Julie  Lamothe              PHONE NO : 760 6071816 
3115 Melrose Dr., Suite 200       SE DECISION MADE: 02-AUG-23
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker MP, Mandible, HMMF and MMF AXS Screws
Stryker Leibinger GmbH & Co. KG   510(k) NO: K231599(Traditional)
ATTN: Amelia  Kesti               PHONE NO : 269 3305919 
Boetzinger Strasse 41             SE DECISION MADE: 24-AUG-23
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
GA Health Company Limited         510(k) NO: K231602(Traditional)
ATTN: Cindy  Ye                   PHONE NO : 852 28339010 
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 01-AUG-23
Hong Kong  HK                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instrument Case
Cochlear Americas                 510(k) NO: K231604(Special)
ATTN: Whitney  Alexander          PHONE NO : 719 3378620 
10350 Park Meadows Drive          SE DECISION MADE: 24-AUG-23
Lone Tree CO  80124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HOLO Portal™ Surgical Guidance System
Surgalign Spine Technologies      510(k) NO: K231611(Traditional)
ATTN: Jeremy  Markovich           PHONE NO : 760 5224378 
520 Lake Cook Road Suite 315      SE DECISION MADE: 31-AUG-23
Deerfield IL  60015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
ZEUS Scientific                   510(k) NO: K231616(Traditional)
ATTN: Mark  Kopnitsky             PHONE NO : 908 5263744 
200 Evans Way                     SE DECISION MADE: 31-AUG-23
Branchburg NJ  08876              510(k) STATEMENT
                                                    

DEVICE: Nuubo Smart
Smart Solutions Technologies SL   510(k) NO: K231620(Traditional)
ATTN: Borja Gonzal Vez            PHONE NO : 
Paseo de la Castellena 200        SE DECISION MADE: 01-AUG-23
Madrid  ES 28046                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Distal Elbow Plating System
Skeletal Dynamics Inc             510(k) NO: K231623(Traditional)
ATTN: Alexandra  Rodriguez Rojas  PHONE NO : 305 5967585 
7300 North Kendall Drive          SE DECISION MADE: 28-AUG-23
Miami FL  33156                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSPREY Closed IV Catheter System (OspreyV2)
SkyDance Vascular, Inc.           510(k) NO: K231626(Traditional)
ATTN: Scott  Pease                PHONE NO : 678 6898010 
3058 Millcreek Road               SE DECISION MADE: 31-AUG-23
Pleasant Grove UT  84062          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NorthStar OCT System
SeaSpine Inc.                     510(k) NO: K231654(Traditional)
ATTN: Jesse  Albright             PHONE NO : 815 3422428 
5770 Armada Dr.                   SE DECISION MADE: 03-AUG-23
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brainomix 360 e-MRI
Brainomix Limited                 510(k) NO: K231656(Traditional)
ATTN: Zsolt  Szrnka               PHONE NO : 0044 79 49013914 
First Floor Seacourt Tower West WaSE DECISION MADE: 30-AUG-23
Oxford  GB OX2 0JJ                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: P200TE (A10700)
Optos Plc                         510(k) NO: K231673(Traditional)
ATTN: Rachel  Reay                PHONE NO : 00 441 383843300 
Queensferry House, Carnegie CampusSE DECISION MADE: 18-AUG-23
Dunfermline  GB KY11 8GR          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CALLISTO eye
Carl Zeiss Meditec AG             510(k) NO: K231676(Traditional)
ATTN: Hans-Joachim  Miesner       PHONE NO : 49 3641 220362 
Goeschwitzer Strasse 51-52        SE DECISION MADE: 28-AUG-23
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccelFix Lumbar Expandable Cage System
L&K BioMed Co., Ltd.              510(k) NO: K231680(Special)
ATTN: Katherine  Kim              PHONE NO : 82 10 54770325 
#101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 24-AUG-23
Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
Prevest Denpro Limited            510(k) NO: K231696(Traditional)
ATTN: Atul  Modi                  PHONE NO : 941___ 9194280 
Unit II, Export Promotion IndustriSE DECISION MADE: 11-AUG-23
Bari Brahmana  IN 181133          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Holmium Medical Laser
Allengers Global Healthcare Privat510(k) NO: K231718(Traditional)
ATTN: Harpreet  Singh             PHONE NO : 91 1762 272600 
Room No.5, Khasra no. 79, BhankarpSE DECISION MADE: 18-AUG-23
Derabassi, District- Mohali  IN 14510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
McGovern Medical School           510(k) NO: K231731(Traditional)
ATTN: K. Lance  Gould             PHONE NO : 713 5006611 
6431 Fannin Street, MSB 4.256     SE DECISION MADE: 21-AUG-23
Houston TX  77030                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MA012 Aluminum wheelchair, MS019 steel wheelchair
Sichuan AST Medical Equipment Co.,510(k) NO: K231750(Traditional)
ATTN: Mae  Tse                    PHONE NO : 86 830 8130333 
No.58 JinPeng Road, Area C, West ISE DECISION MADE: 15-AUG-23
Luzhou City  CN 646100            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stable-C Interbody System
Nexus Spine, LLC                  510(k) NO: K231763(Traditional)
ATTN: Jared  Crocker              PHONE NO : 801 7028592 
2825 East Cottonwood Parkway SuiteSE DECISION MADE: 21-AUG-23
Salt Lake City UT  84121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
Olympus Winter & Ibe GmbH         510(k) NO: K231777(Traditional)
ATTN: Ian  Pericevic              PHONE NO : 49 40 669660 
Kuehnstrasse 61                   SE DECISION MADE: 18-AUG-23
Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: primaLOK™ SP Interspinous Fusion System
Wenzel Spine, Inc.                510(k) NO: K231807(Traditional)
ATTN: William  Wilson             PHONE NO : 512 4690600 
1130 Rutherford Lane, Suite 200   SE DECISION MADE: 15-AUG-23
Austin TX  78753                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zavation Connector System
Zavation Medical Products, LLC    510(k) NO: K231811(Traditional)
ATTN: Noah  Slack                 PHONE NO : 601 9191119 
3670 Flowood Dr.                  SE DECISION MADE: 22-AUG-23
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOxBOXi Nitric Oxide Delivery System
Linde Gas & Equipment Inc.        510(k) NO: K231823(Special)
ATTN: Dave  Loflin                PHONE NO : 412 8743315 
208 W Main St.                    SE DECISION MADE: 11-AUG-23
Livingston TN  38570              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xenix Medical Sacroiliac Fixation System
HT Medical d.b.a. Xenix Medical   510(k) NO: K231829(Traditional)
ATTN: Teresa  Cherry              PHONE NO : 888 5948633 
111 W Jefferson St., Suite 100    SE DECISION MADE: 15-AUG-23
Orlando FL  32801                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TiLink-L Joint Fusion System
SurGenTec                         510(k) NO: K231831(Special)
ATTN: Andrew  Shoup               PHONE NO : 561 9907882 
911 Clint Moore Rd                SE DECISION MADE: 03-AUG-23
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RxSight® Insertion Device (63002)
RxSight, Inc.                     510(k) NO: K231838(Traditional)
ATTN: Maureen  OConnell           PHONE NO : 978 2071245___ 
100 Columbia                      SE DECISION MADE: 15-AUG-23
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex TightRope II
Arthrex Inc.                      510(k) NO: K231857(Traditional)
ATTN: Kristi  Frisch              PHONE NO : 1 239 5984302 73849
1370 Creekside Boulevard          SE DECISION MADE: 08-AUG-23
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Grappler Suture Anchor System
Paragon 28, Inc.                  510(k) NO: K231867(Traditional)
ATTN: Edward  Wells-Spicer        PHONE NO : 585 4552810 
14445 Grasslands Dr               SE DECISION MADE: 21-AUG-23
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)
Kirwan Surgical Products LLC      510(k) NO: K231872(Traditional)
ATTN: Matthew  Prario             PHONE NO : 781 8349500 
180 Enterprise Drive              SE DECISION MADE: 25-AUG-23
Marshfield MA  02050              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline UNITE® REFLEX® Nitinol Staple System
Medline Industries, LP            510(k) NO: K231885(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
Three Lakes Drive                 SE DECISION MADE: 09-AUG-23
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Montage-QS Settable, Resorbable Bone Putty
Orthocon, Inc.                    510(k) NO: K231903(Traditional)
ATTN: Aniq  Darr                  PHONE NO : 855 4759175 
700 Fairfield Avenue- Suite 1     SE DECISION MADE: 25-AUG-23
Stamford CT  06902                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electro-Spec Steri-Caps
Electro-Spec, Inc                 510(k) NO: K231905(Traditional)
ATTN: Jeff  Smith                 PHONE NO : 1 317 7390924 
1800 Commerce Parkway             SE DECISION MADE: 14-AUG-23
Franklin IN  46131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mineral Collagen Composite Bioactive Extra Moldable
Collagen Matrix, Inc.             510(k) NO: K231942(Special)
ATTN: Victoria  Augustine         PHONE NO : 646 2229564 
15 Thornton Rd.                   SE DECISION MADE: 02-AUG-23
Oakland NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CATAMARAN SI Joint Fusion System
Tenon Medical, Inc.               510(k) NO: K231944(Traditional)
ATTN: Susan  Noreiga              PHONE NO : 650 7931966 
104 Cooper Court                  SE DECISION MADE: 24-AUG-23
Los Gatos CA  95032               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aristotle 18 Guidewire; Aristotle 24 Guidewire
Scientia Vascular, Inc.           510(k) NO: K231954(Special)
ATTN: Bailey  Johannsen           PHONE NO : 888 3859016 
2460 S 3270 W                     SE DECISION MADE: 01-AUG-23
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXPD 4357; EXPD 4357P
DRTECH Corporation                510(k) NO: K231959(Special)
ATTN: Lee  Youna                  PHONE NO : 82 31 7797710 
Suite No.1, 2 Floor/Suite No. 2, 3SE DECISION MADE: 01-AUG-23
Seongnam-si  KR 13216             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NIBPCuff
Shenzhen SINO-K Medical Technology510(k) NO: K231961(Traditional)
ATTN: Lao  Chengxin               PHONE NO : 86 137 15333326 
Room401,Bldg2,Veteran Ind.city,GonSE DECISION MADE: 30-AUG-23
Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REAL INTELLIGENCE™ CORI™
Blue Belt Technologies, Inc.      510(k) NO: K231963(Special)
ATTN: Corrine  Herlinger          PHONE NO : 412 5526428 
2875 Railroad Street              SE DECISION MADE: 01-AUG-23
Pittsburgh PA  15222              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50
VivaChek Biotech (Hangzhou) Co., L510(k) NO: K231978(Traditional)
ATTN: Jessica  Chen               PHONE NO : 86 182 57349413 
Floor 2, Block 2, 146 East ChaofenSE DECISION MADE: 31-AUG-23
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
Thermo Fisher Scientific          510(k) NO: K231988(Traditional)
ATTN: Joel  Mathew                PHONE NO : 978 9074417 
One Thermo Fisher Way             SE DECISION MADE: 30-AUG-23
Oakwood Village OH  44146         510(k) STATEMENT
                                                    

DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL
Thermo Fisher Scientific          510(k) NO: K231994(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 1 216 2122844 
One Thermo Fisher Way             SE DECISION MADE: 25-AUG-23
Oakwood Village OH  44146         510(k) STATEMENT
                                                    

DEVICE: HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)
Smith & Nephew, Inc.              510(k) NO: K232005(Special)
ATTN: Camille  Fleischer          PHONE NO : 978 7491057 
150 Minuteman Road                SE DECISION MADE: 04-AUG-23
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LEGACY®  IPC
IG Technology Ltd                 510(k) NO: K232006(Third Party - Traditional)
ATTN: Ivan  Green                 PHONE NO : 440 7770 386797 
Wylcut House, 316 Petre St        SE DECISION MADE: 04-AUG-23
Sheffield  GB S33 0AW             510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: Disposable Medical Examination Nitrile Gloves
Raxwell Industrial LLC            510(k) NO: K232008(Third Party - Traditional)
ATTN: Xianda  Yao                 PHONE NO : 1 765 4300178___ 
20323 Bristol Bluff Ln            SE DECISION MADE: 08-AUG-23
Richmond TX  77407                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: iTEMPSHIELD
AION Biosystems Inc.              510(k) NO: K232010(Third Party - Traditional)
ATTN: Joseph  Azary               PHONE NO : 203 2426670 
12 Plymouth Road                  SE DECISION MADE: 04-AUG-23
Darien CT  06820                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
ATMOS MedizinTechnik GmbH & Co. KG510(k) NO: K232015(Traditional)
ATTN: Reinhold  Storch            PHONE NO : 49 7653 689647 
Ludwig-Kegel-Str. 16              SE DECISION MADE: 03-AUG-23
Lenzkirch  DE 79853               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ingenia Elition R5.7.1 SP4 MR Systems
Philips Medical Systems Nederland 510(k) NO: K232030(Special)
ATTN: Ioana  Ulea                 PHONE NO : 31 618 345875 
Veenpluis 6                       SE DECISION MADE: 02-AUG-23
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Grand Work Plastic Products Co., L510(k) NO: K232039(Special)
ATTN: Wu  Yuli                    PHONE NO : 86 311 66179668 
Donggao Industrial Zone           SE DECISION MADE: 09-AUG-23
Zanhuang  CN 050000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceribell Instant EEG Headband
Ceribell, Inc.                    510(k) NO: K232052(Special)
ATTN: Raymond  Woo                PHONE NO : 650 5564349 
360 North Pastoria Avenue         SE DECISION MADE: 08-AUG-23
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YosemiteView 4343W/YosemiteView 3643W
CareRay Digital Medical Technology510(k) NO: K232058(Special)
ATTN: Xu  Wei                     PHONE NO : 86 512 86860288 
A2-201/B3-501, Biobay,218 Xinghu SSE DECISION MADE: 03-AUG-23
Suzhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Efai Pacs Picture Archiving and Communication System Pro
Ever Fortune.AI Co., Ltd.         510(k) NO: K232100(Special)
ATTN: Joseph  Chang               PHONE NO : 866 4 23226363 
8 F., No. 573, Sec. 2, Taiwan BlvdSE DECISION MADE: 08-AUG-23
Taichung City  TW 403020          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoreLink Navigation Instruments
CoreLink, LLC                     510(k) NO: K232116(Special)
ATTN: Steven  Mounts              PHONE NO : 888 3497808___ 
2072 Fenton Logistics Park        SE DECISION MADE: 16-AUG-23
St. Louis MO  63026               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
Covidien                          510(k) NO: K232126(Special)
ATTN: Helen  Chen                 PHONE NO : 86 21 33230135 
Room 501, 502, 601, 602, No. 3 BuiSE DECISION MADE: 16-AUG-23
Min Hang District, Shanghai  CN 20510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 21HQ513D, 32HL512D, 31HN713D, 32HQ713D
LG Electronics Inc.               510(k) NO: K232127(Special)
ATTN: Daseul  An                  PHONE NO : 82 31 80665641 
168, Suchul-daero                 SE DECISION MADE: 15-AUG-23
Gumi-si  KR 39368                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LifeSPARC System
CardiacAssist, Inc.               510(k) NO: K232132(Special)
ATTN: Arielle  Drummond           PHONE NO : 412 8899021 
620 Alpha Drive                   SE DECISION MADE: 03-AUG-23
Pittsburgh PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K232141(Special)
ATTN: Kelly  McDonnell            PHONE NO : 1 651 2699806 
1800 Pyramid Place                SE DECISION MADE: 16-AUG-23
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Products of the APTUS System
Medartis AG                       510(k) NO: K232144(Special)
ATTN: Claudia  De Santis          PHONE NO : 41 61 6333434 
Hochbergerstrasse 60E             SE DECISION MADE: 18-AUG-23
Basel  CH 4057                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZSFab Cervical Interbody System
ZSFab Inc.                        510(k) NO: K232150(Special)
ATTN: Xuewei  Ma                  PHONE NO : 617 4688665 
96 Clematis Ave, Suite 2F         SE DECISION MADE: 18-AUG-23
Walthan MA  02453                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avéli
Revelle Aesthetics, Inc.          510(k) NO: K232153(Special)
ATTN: Melissa  Viotti             PHONE NO : 650 3365985 
2570 W El Camino Real, Suite 310  SE DECISION MADE: 18-AUG-23
Mountain View CA  94040           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
Stryker Corporation               510(k) NO: K232157(Special)
ATTN: Janki  Bhatt                PHONE NO : 669 2153045 
5900 Optical Ct                   SE DECISION MADE: 18-AUG-23
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome
Boston Scientific Corporation     510(k) NO: K232162(Special)
ATTN: Stephanie  Gorman           PHONE NO : 508 3820441 
100 Boston Scientific Way         SE DECISION MADE: 14-AUG-23
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SM-IV
Sedecal SA                        510(k) NO: K232185(Special)
ATTN: Mª Luisa Gómez  de Agüero   PHONE NO : 34 91 6280544 
C/ Pelaya, 9 - 13 Pol. Ind. Río DeSE DECISION MADE: 21-AUG-23
Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
Medtronic Vascular                510(k) NO: K232190(Special)
ATTN: Colleen  Gentile            PHONE NO : 1 508 8436178 
37A Cherry Hill Drive             SE DECISION MADE: 22-AUG-23
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OMNI Surgical System
Sight Sciences Inc.,              510(k) NO: K232214(Special)
ATTN: Ranjani  Madhavan           PHONE NO : 737 2470998 
4040 Campbell Ave, Suite 100      SE DECISION MADE: 25-AUG-23
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantra Hemostasis Analyzer
HemoSonics, LLC                   510(k) NO: K232215(Special)
ATTN: Debbie  Winegar             PHONE NO : 919 2446990 
4020 Stirrup Creek Drive, Suite 10SE DECISION MADE: 24-AUG-23
Durham NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zenius™ Spinal System
Medyssey USA, Inc.                510(k) NO: K232218(Special)
ATTN: Youngsu  Jang               PHONE NO : 847 4270200 
43176 Business Park Dr Ste 107    SE DECISION MADE: 24-AUG-23
Temecula CA  92590                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARROW Off-Centred Humeral Insert
FH Industrie                      510(k) NO: K232226(Special)
ATTN: Naoual  Rahimi              PHONE NO : 33 02 56102046 
6 rue Nobel, Zi De Kernevez       SE DECISION MADE: 29-AUG-23
Quimper  FR 29000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVO 700 series high speed handpiece
Ttbio Corp.                       510(k) NO: K232243(Special)
ATTN: Sheng-Chieh  Su             PHONE NO : 886 4 23595958 
2F., No.7, 6th Road Industry Park SE DECISION MADE: 23-AUG-23
Taichung  CN 40755                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RAYSCAN a-Expert3D
Ray Co., Ltd.                     510(k) NO: K232287(Special)
ATTN: Sooji  Huh                  PHONE NO : 82 605 1000 
1F~3F, 4F(Part), 5F, 265, Daeji-RoSE DECISION MADE: 31-AUG-23
Yongin-si  KR 16882               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Essenz HLM, Essenz ILBM
LivaNova Deutschland GmbH         510(k) NO: K232291(Special)
ATTN: Florian  Goetz              PHONE NO : 49 89 32301236 
Lindberghstr. 25                  SE DECISION MADE: 24-AUG-23
Munich  DE 80939                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LAA Exclusion System
Syntheon, LLC                     510(k) NO: K232295(Special)
ATTN: Toygar  Unal                PHONE NO : 973 9978532 
13755 SW 119 Avenue               SE DECISION MADE: 30-AUG-23
Miami FL  33186                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
L&K Biomed Co., Ltd.              510(k) NO: K232311(Special)
ATTN: Katherine  Kim              PHONE NO : 82 10 54770325 
#101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 14-AUG-23
Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)
Ethicon Endo Surgery, LLC.        510(k) NO: K232313(Special)
ATTN: Lakrisha  Tinner            PHONE NO : 517 3377475 
475 Calle C                       SE DECISION MADE: 29-AUG-23
Guaynabo  PR 00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StealthFix Intraosseous Fixation System
Medartis Inc.                     510(k) NO: K232324(Special)
ATTN: Chelsea  Kozior             PHONE NO : 610 7318650 
1195 Polk Drive                   SE DECISION MADE: 30-AUG-23
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AC3™ Series IABP
Arrow International, LLC          510(k) NO: K232343(Special)
ATTN: Sheila  Payzant             PHONE NO : 763 6564290 
3015 Carrington Mill Blvd         SE DECISION MADE: 30-AUG-23
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Black)
Shanxi Hongjin Plastic Technology 510(k) NO: K232353(Special)
ATTN: Wu  Zhigang                 PHONE NO : 86 311 66179668 
Coal Bed Gas Industrial Zone, Qu'eSE DECISION MADE: 31-AUG-23
Linfen  CN 042300                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Treace Medical Concepts (TMC) Compression Implant System
Treace Medical Concepts           510(k) NO: K232387(Special)
ATTN: Brittany  Grochala          PHONE NO : 515 8650494 
100 Palmetto Park Place           SE DECISION MADE: 28-AUG-23
Ponte Vedra FL  32081             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
Ultradent Product, Inc.           510(k) NO: K232498(Third Party - Traditional)
ATTN: Ruth  Gardner               PHONE NO : 801 5534431 
505 West Ultradent Drive (10200 SoSE DECISION MADE: 18-AUG-23
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

               TOTAL 510(k)s THIS PERIOD   310                                     
               TOTAL WITH SUMMARIES        289                                     
               TOTAL WITH STATEMENTS        21
                                      
 
Back to Top