510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2023
DEVICE: Meril-Bonewax
M/s. Meril Endo Surgery Private Li510(k) NO: K200452(Traditional)
ATTN: Umesh Sharma PHONE NO : 91 260 3052100 3811
Third Floor, E1-E3, Meril Park, SuSE DECISION MADE: 27-MAR-23
Chala, Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CereFlow V1.2
Translational MRI, LLC 510(k) NO: K211059(Traditional)
ATTN: Zhihai Ricky Xiang PHONE NO : 1 530 7609006
3200 S Sepulveda Blvd Suite K30 SE DECISION MADE: 31-MAR-23
Los Angeles CA 90034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VHT-200 Wound Treatment System
Vaporox, Inc. 510(k) NO: K212121(Traditional)
ATTN: Alan Sage PHONE NO : 303 5585145
7012 S. Revere Pkwy, Suite 100 SE DECISION MADE: 23-MAR-23
Centennial CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
Masimo Corporation 510(k) NO: K212161(Traditional)
ATTN: Katelynn Kirby PHONE NO : 949 2977408
52 Discovery SE DECISION MADE: 06-MAR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Syringe for Single Use
Shandong Weigao Group Medical Poly510(k) NO: K212207(Traditional)
ATTN: Lina Liu PHONE NO : 86 631 5716818
No.18 Xingshan Road, Torch Hi-techSE DECISION MADE: 23-MAR-23
Weihai CN 264210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Implant-One Multi-Unit Abutment
Implant Logistics, Inc. 510(k) NO: K212394(Traditional)
ATTN: Thomas Arendt PHONE NO : 608 4984855
711 Spartan Drive SE DECISION MADE: 23-MAR-23
Sparta WI 54656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoDrill® Model X
Bibbinstruments AB 510(k) NO: K212423(Traditional)
ATTN: Marie Grey PHONE NO : 46 70 5902144
Scheelevagen 2 SE DECISION MADE: 29-MAR-23
Lund SE S-223 63 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aspira Pleural Drainage System
Merit Medical Systems, Inc. 510(k) NO: K212696(Traditional)
ATTN: Jennifer Webb PHONE NO : 801 2084247
1600 West Merit Parkway SE DECISION MADE: 03-MAR-23
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HeartBuds Electronic Stethoscope
Heartbuds LLC 510(k) NO: K212906(Traditional)
ATTN: Seth Ellis PHONE NO : 407 9062484
711 London Road SE DECISION MADE: 14-MAR-23
Winter Park FL 32792 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETT PLASMA Medical II
Compex, Spol. s.r.o 510(k) NO: K213247(Traditional)
ATTN: Eva Hamplova PHONE NO : 42 077 0156562
Palackeho Trida 924/105 SE DECISION MADE: 14-MAR-23
Brno CZ 61200 510(k) STATEMENT
DEVICE: Formus Hip
Formus Labs, Ltd 510(k) NO: K213272(Traditional)
ATTN: Ju Zhang PHONE NO : 64 9 9526538
Suite 5, Floor 3, 30 St Benedicts SE DECISION MADE: 31-MAR-23
Auckland NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
BioFire Defense, LLC 510(k) NO: K213362(Traditional)
ATTN: Cynthia Phillips PHONE NO : 801 2623592 1370
79 W 4500 S, Suite 14 SE DECISION MADE: 22-MAR-23
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadAlly
Imaging Wave, LLC 510(k) NO: K213660(Abbreviated)
ATTN: Edward Kantor PHONE NO : 917 5827761
7023 Juno Street SE DECISION MADE: 31-MAR-23
Forrest Hills NY 11375 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avoset Infusion Pump System
Eitan Medical Ltd. 510(k) NO: K213744(Traditional)
ATTN: Guy Mlechkovich PHONE NO : 972 72 3359882
29 Yad Haruzim St. SE DECISION MADE: 10-MAR-23
Netanya IL 4250529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SiJoin®T3
VGI Medical, Inc. 510(k) NO: K213815(Traditional)
ATTN: Tov Vestgaarden PHONE NO : 727 5651235
11651 87th Street SE DECISION MADE: 29-MAR-23
Largo FL 33773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carestation 750/750c
Datex-Ohmeda, Inc. 510(k) NO: K213867(Traditional)
ATTN: Kimberly Mangum PHONE NO : 267 4005180
3030 Ohmeda Drive, PO Box 7550 SE DECISION MADE: 28-MAR-23
Madison WI 53707-7550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
RB Health (US) LLC 510(k) NO: K213892(Traditional)
ATTN: Joseph Macfarlane PHONE NO : 862 3250012
399 Interpace Parkway SE DECISION MADE: 07-MAR-23
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProTrack Pigtail Wire
Baylis Medical Company Inc. 510(k) NO: K213898(Traditional)
ATTN: May Tsai PHONE NO : 905 6024875
5825 Explorer Dr. SE DECISION MADE: 01-MAR-23
Mississauga CA L4W 5P6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: extriCARE 1000 Negative Pressure Wound Therapy System
Alleva Medical Ltd 510(k) NO: K213906(Traditional)
ATTN: Max Choi PHONE NO : 852 31667200
Suite M-Q, 12th Floor, Kings Wing SE DECISION MADE: 08-MAR-23
Shek Mun HK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
Biomet Manufacturing Corp. 510(k) NO: K214001(Traditional)
ATTN: Aishwarya Pandey PHONE NO : 1 574 3733740
56 East Bell Drive SE DECISION MADE: 15-MAR-23
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OviTex PRS (Long Term Resorbable)
TELA Bio 510(k) NO: K214070(Traditional)
ATTN: John Urtz PHONE NO : 610 6592266
1 Great Valley Parkway, Suite 24 SE DECISION MADE: 21-MAR-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RSHOCK
SWIMS America Corp 510(k) NO: K220014(Traditional)
ATTN: Matthieu Commeau PHONE NO : 917 3717388
1133 Westchester Avenue Suite N 22SE DECISION MADE: 01-MAR-23
White Plains NY 10604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genomadix Cube CYP2C19 System
Genomadix Inc. 510(k) NO: K220026(Abbreviated)
ATTN: Amanda Dwyer PHONE NO : 1 877 2287756
340 Legget Drive, Suite 180 SE DECISION MADE: 21-MAR-23
Kanata (Ottawa) CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Butterfly iQ/iQ+ Ultrasound System
Butterfly Network, Inc. 510(k) NO: K220068(Traditional)
ATTN: Brian Sawin PHONE NO : 855 4586188
530 Old Whitfield Street SE DECISION MADE: 31-MAR-23
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Professional Latex Sdn Bhd 510(k) NO: K220088(Traditional)
ATTN: Kok Yoon Lim PHONE NO : 60 126 873020
Lot 20734 & 20735, Lengkungan PeruSE DECISION MADE: 30-MAR-23
Kawasan Perusahaan Kamunting Raya 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Beijing Choice Electronic Technolo510(k) NO: K220101(Traditional)
ATTN: Haiying Zhao PHONE NO : 86 10 88794631
2nd Floor 3rd Floor and Room 410-4SE DECISION MADE: 08-MAR-23
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX 6
RF Innovations, Inc 510(k) NO: K220122(Traditional)
ATTN: William Rittman PHONE NO : 781 6401212
30 Log Bridge Road SE DECISION MADE: 15-MAR-23
Middleton MA 01949 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder
Becton, Dickinson and Company 510(k) NO: K220212(Traditional)
ATTN: Kelly Hilliger PHONE NO : 551 5541675
1 Becton Drive SE DECISION MADE: 24-MAR-23
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Y Lubricating Jelly
R&R Medical Corporation Ltd 510(k) NO: K220226(Traditional)
ATTN: Wilson Chang PHONE NO : 886 2 26976618
No.4, Ln. 38, Zhongxing N. St., SaSE DECISION MADE: 28-MAR-23
New Taipei City TW 24158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precice Intramedullary Limb Lengthening System
NuVasive Specialized Orthopedics, 510(k) NO: K220234(Traditional)
ATTN: Madison Heffron PHONE NO : 949 5327868
101 Enterprise, Suite 100 SE DECISION MADE: 15-MAR-23
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
Scientia Vascular, LLC 510(k) NO: K220398(Special)
ATTN: Thomas Lippert PHONE NO : 888 3859016
3487 W 2100 S Suite 100 SE DECISION MADE: 10-MAR-23
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visby Medical Sexual Health Test
Visby Medical 510(k) NO: K220407(Dual Track)
ATTN: Beth Lingenfelter PHONE NO : 1 801 6805475
3010 N 1st Street SE DECISION MADE: 07-MAR-23
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tigon Medical Gryphon Anchor Line
Tigon Medical 510(k) NO: K220464(Traditional)
ATTN: Jeremy Clark PHONE NO : 410 5442833
303 Najoles Rd SE DECISION MADE: 22-MAR-23
Millersville MD 21108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
Hans Biomed Corporation 510(k) NO: K220549(Traditional)
ATTN: Lucy Choi PHONE NO : 82 3 54362436
64, Yuseong-Daero 1628 Beon-Gil SE DECISION MADE: 07-MAR-23
Yuseong-Gu KR 34054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
Bausch & Lomb Incorporated 510(k) NO: K220613(Traditional)
ATTN: Barbara Klube-Falso PHONE NO : 585 3388503
1400 North Goodman street SE DECISION MADE: 08-MAR-23
Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
YTY Industry (Manjung) Sdn Bhd 510(k) NO: K220644(Traditional)
ATTN: Punitha Samy PHONE NO : 605 69 08533
Lot 1422-1424, Batu 10 Lekir SE DECISION MADE: 25-MAR-23
Sitiawan MY 32020 510(k) STATEMENT
DEVICE: Sterile Silver Alginate Wound Dressing
Qingdao Bright Moon Biomedical Mat510(k) NO: K220673(Traditional)
ATTN: Deng Yunlong PHONE NO : 86 186 69829719
No. 788, Bright Moon Road, HuangdaSE DECISION MADE: 16-MAR-23
Qingdao CN 266400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HPR45i
F Care Systems USA LLC 510(k) NO: K220725(Traditional)
ATTN: Patrick Danciu PHONE NO : 786 2880740
11098 Biscayne Blvd Suite 301 SE DECISION MADE: 20-MAR-23
Miami FL 33161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROVO Mechanical Thrombectomy Device
2MG, Inc 510(k) NO: K220780(Traditional)
ATTN: Ted Karmon PHONE NO : 269 2077888
176 N Nanagosa SE DECISION MADE: 31-MAR-23
Suttons Bay MI 49682 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simplexa COVID-19 & Flu A/B Direct
DiaSorin Molecular LLC 510(k) NO: K220963(Traditional)
ATTN: Sharon Young PHONE NO : 562 2406680
11331 Valley View Street SE DECISION MADE: 17-MAR-23
Cypress CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINEFIX
BAAT Medical Products B.V. 510(k) NO: K220966(Traditional)
ATTN: Jasper Springer PHONE NO : 31 088 5656600
F. Hazemeijerstraat 800-Building ASE DECISION MADE: 08-MAR-23
Hengelo NL 7555 RJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magnes-C Anterior Cervical Plate System
Fellowship of Orthopaedic Research510(k) NO: K221053(Traditional)
ATTN: Stephen D. Cook PHONE NO : 504 3099845
320 Metairie Hammond Highway, SuitSE DECISION MADE: 01-MAR-23
Metairie LA 70005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dyna Locking Trochanteric Nail™
Innosys 510(k) NO: K221084(Special)
ATTN: Yu-jin Kang PHONE NO : 82 31 8606800
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 03-MAR-23
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RCRP Flex reagent cartridge
Siemens Healthcare Diagnostics Inc510(k) NO: K221119(Special)
ATTN: Ian Thompson PHONE NO : 914 2176666
511 Benedict Avenue SE DECISION MADE: 17-MAR-23
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CloudTMS for OCD
TeleEMG, LLC 510(k) NO: K221129(Traditional)
ATTN: Joe F Jabre PHONE NO : 617 8403253
7304 Beverly Blvd, #357 SE DECISION MADE: 10-MAR-23
Los Angeles CA 90036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Video Flexible Ureterorenoscope System
Guangzhou Red Pine Medical Instrum510(k) NO: K221158(Traditional)
ATTN: Lifang Zhang PHONE NO : 86 20 38315611
Room 303, 308, No. 12, Luoxuan 3 RSE DECISION MADE: 06-MAR-23
Guangzhou CN 510200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
Thermo Fisher Scientific 510(k) NO: K221198(Traditional)
ATTN: Cynthia Knapp PHONE NO : 800 8718909
1 Thermo Fisher Way SE DECISION MADE: 10-MAR-23
Oakwood Village OH 44146 510(k) STATEMENT
DEVICE: PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
PADM Medical Inc. 510(k) NO: K221209(Traditional)
ATTN: Xiomara Perdomo PHONE NO : 1 204 2894491 224
1595 Buffalo Place SE DECISION MADE: 08-MAR-23
Winnipeg CA R3T 1L9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uni Knee Resurfacing System
Overture Resurfacing Inc. 510(k) NO: K221292(Traditional)
ATTN: Riley Williams PHONE NO :
1617 3rd Ave, #287284 SE DECISION MADE: 10-MAR-23
New York NY 10128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESS Dental Smart Solutions
Terrats Medical SL 510(k) NO: K221301(Traditional)
ATTN: Roger Terrats PHONE NO : 34 935 646006
Carrer Mogoda 75-99 SE DECISION MADE: 09-MAR-23
Barberà del Vallès ES 08210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
Nidek Co., LTD. 510(k) NO: K221320(Traditional)
ATTN: Tsutomu Sunada PHONE NO : 81 533 678901
34-14 Maehama, Hiroishi-cho SE DECISION MADE: 30-MAR-23
Gamagori JP 443-0038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
Camber Spine Technologies 510(k) NO: K221324(Traditional)
ATTN: Noel Hetrick PHONE NO : 484 4277060
501 Allendale Road SE DECISION MADE: 30-MAR-23
King of Prussia PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)
Boston Scientific Corporation 510(k) NO: K221340(Traditional)
ATTN: Inderdeep Tiwana PHONE NO :
100 Boston Scientific Way SE DECISION MADE: 02-MAR-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Wuhan Huashida Protective Products510(k) NO: K221352(Traditional)
ATTN: Chen Mei PHONE NO : 86 189 71272798
No.511 Weihu Rd, Shamao St, HannanSE DECISION MADE: 13-MAR-23
Wuhan, CN 430090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Essenz HLM
LivaNova Deutschland GmbH 510(k) NO: K221373(Traditional)
ATTN: Julia E. Leslie PHONE NO : 49 89 32301141
Lindberghstr. 25 SE DECISION MADE: 09-MAR-23
Munich DE 80939 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEREC Tessera Abutment Block, CEREC Tessera Abutment System
Dentsply Sirona Inc. 510(k) NO: K221402(Traditional)
ATTN: Courtney Clark PHONE NO : 248 8954379
221 West Philadelphia Street, SuitSE DECISION MADE: 22-MAR-23
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MagVenture TMS Atlas Neuro Navigation System
Tonica Elektronik A/S 510(k) NO: K221544(Traditional)
ATTN: Jan Kjoller PHONE NO : 45 2489 9976
Lucernemarken 15 SE DECISION MADE: 17-MAR-23
Farum DK DK-3520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
3M Health Care Business Group 510(k) NO: K221585(Traditional)
ATTN: Margaret Marsh PHONE NO : 210 2556481
6203 Farinon Dr SE DECISION MADE: 23-MAR-23
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DHX-70H, XTG-70H
DIGIMED Co., Ltd. 510(k) NO: K221587(Traditional)
ATTN: Youngbae Kwon PHONE NO : 82 2 26241551
145, Gasan digital 1-ro, GeumcheonSE DECISION MADE: 03-MAR-23
Seoul KR 08506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Starly pad
Shenzhen Xingyuanli Technology Co.510(k) NO: K221589(Traditional)
ATTN: Tse Adrian PHONE NO : 086 1591 5873605
4/F, No.1, TianShiDa Industrial PaSE DECISION MADE: 24-MAR-23
Zhezhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pro-X1™ Trochanteric Nailing System
X-Bolt Orthopedics 510(k) NO: K221621(Traditional)
ATTN: Brian Thornes PHONE NO : 353 1 4433880
Unit 5 Northwood Court SE DECISION MADE: 06-MAR-23
Santry IE 9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
GME German Medical Engineering Gmb510(k) NO: K221623(Traditional)
ATTN: Dietmar Fischer PHONE NO : 49 9131 93415911
Dreikoenigstr. 6-8 SE DECISION MADE: 10-MAR-23
Erlangen DE 91054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIKKICART
Renal Care Dialysis Solutions, S.A510(k) NO: K221652(Traditional)
ATTN: Jose Enrique Aguirre ValadesPHONE NO : 521 5536 558830
Carretera a los Cues K.M. 2.2, LotSE DECISION MADE: 03-MAR-23
El Marques MX 76246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
Compression Works Inc 510(k) NO: K221661(Traditional)
ATTN: John Croushorn PHONE NO : 205 2021136
1634-A Montgomery Hwy #115 SE DECISION MADE: 03-MAR-23
Hoover AL 35216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xeleris V Processing and Review System
GE Healthcare 510(k) NO: K221680(Traditional)
ATTN: George Mashour PHONE NO : 972 4 8563666 639
4 Hayozma Street SE DECISION MADE: 01-MAR-23
Tirat Hacarmel IL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReWalk P6.0
ReWalk Robotics Ltd. 510(k) NO: K221696(Traditional)
ATTN: Miri Pariente PHONE NO : 972 58 5605090
3 Hatnufa St. POB Box-161 SE DECISION MADE: 02-MAR-23
Yokneam IL 2069203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INJECTION PIN (KIP(02031-02061) (03031-03061))
SLK Ortho Llc 510(k) NO: K221697(Traditional)
ATTN: Lawrence Kluge PHONE NO : 847 6301818
5883 RFD SE DECISION MADE: 03-MAR-23
Long Grove IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AutoPulse NXT Resuscitation System
ZOLL Circulation, Inc. 510(k) NO: K221700(Traditional)
ATTN: Brian Robey PHONE NO : 978 8059015
2000 Ringwood Avenue SE DECISION MADE: 09-MAR-23
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuContour
Manteia Technologies Co., Ltd. 510(k) NO: K221706(Traditional)
ATTN: Dandan Chen PHONE NO : 86 0592 6100813
1903, B Tower, Zijin Plaza No. 181SE DECISION MADE: 09-MAR-23
Xiamen CN 361001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polypectomy Snare
Hangzhou AGS MedTech Co., Ltd. 510(k) NO: K221713(Traditional)
ATTN: Jiayuan Zhang PHONE NO : 86 571 87671223
Building 5, Building 6, No. 597 KaSE DECISION MADE: 03-MAR-23
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMR Stemless Anatomic
LimaCorporate S.p.A 510(k) NO: K221758(Traditional)
ATTN: Roberto Gabetta PHONE NO : 39 338 6439379
Via Nazionale 52 SE DECISION MADE: 17-MAR-23
San Daniele del Friuli IT 33038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroRPM
New Touch Digital Inc. 510(k) NO: K221772(Traditional)
ATTN: Chan Lee PHONE NO : 703 2019548
3124 Dumbarton Street NW SE DECISION MADE: 17-MAR-23
Washington DC 20007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
Merit Medical Pte. Ltd. 510(k) NO: K221782(Traditional)
ATTN: Pauline Liow PHONE NO : 65 67509281
198 Yishun Avenue 7 SE DECISION MADE: 17-MAR-23
Singapore SG 768926 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccurSound Electronic Stethoscope AS-101
Heroic Faith International Ltd. 510(k) NO: K221805(Traditional)
ATTN: Yuan-Ren Cheng PHONE NO : 88 622 6590291___
18F., No. 460, Section 4, Xinyi RoSE DECISION MADE: 23-MAR-23
Taipei City TW 110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InterOss Collagen
SigmaGraft Inc. 510(k) NO: K221808(Traditional)
ATTN: Elcin Chang PHONE NO : 714 5250114
575 Sally Place SE DECISION MADE: 18-MAR-23
Fullerton CA 92831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wesper Lab
Wesper Inc. 510(k) NO: K221816(Traditional)
ATTN: Amir Reuveny PHONE NO : 516 6544166
234 5th Ave SE DECISION MADE: 09-MAR-23
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EOlife®
ARCHEON 510(k) NO: K221841(Traditional)
ATTN: Valentine OQDA PHONE NO : 33 3816 62380
2 Chemin des Aiguillettes SE DECISION MADE: 18-MAR-23
Besançon FR 25000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
Nova Eye Inc. (Business name Nova 510(k) NO: K221872(Abbreviated)
ATTN: Don Watton PHONE NO : 61 417 865044
41316 Christy St. SE DECISION MADE: 30-MAR-23
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solero Microwave Tissue Ablation (MTA) System and Accessories
AngioDynamics, Inc. 510(k) NO: K221883(Special)
ATTN: Kasey E Newcomb PHONE NO : 508 6587813___
26 Forest Street SE DECISION MADE: 07-MAR-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ Bipolar Resectoscopes with HF Cable
KARL STORZ Endoscopy America, Inc 510(k) NO: K221893(Traditional)
ATTN: Leigh Spotten PHONE NO : 424 2188184
2151 E. Grand Avenue SE DECISION MADE: 17-MAR-23
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
Hemodia SAS 510(k) NO: K221919(Traditional)
ATTN: Anne-Lyse Miard PHONE NO : 33 5 32980243
ZI Bourgade, 85 Rue du Chene Vert SE DECISION MADE: 09-MAR-23
Labege FR 31670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DTX Studio Clinic 3.0
Nobel Biocare AB 510(k) NO: K221921(Traditional)
ATTN: Wim Vrydag PHONE NO : 32 15443200
Vastra Hamngatan 1 SE DECISION MADE: 28-MAR-23
411 17 Goteborg SE 402 26 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Routines
GNC Holdings, LLC 510(k) NO: K221924(Traditional)
ATTN: YongKai Wong PHONE NO : 412 2193879
75 Hopper Pl SE DECISION MADE: 15-MAR-23
Pittsburgh PA 15222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEREGLIDE 71 Intermediate Catheter
Cerenovus, Inc. 510(k) NO: K221930(Traditional)
ATTN: Ariell Joner PHONE NO : 908 7269577
6303 Blue Lagoon Drive, Suite 215 SE DECISION MADE: 09-MAR-23
Miami FL 33126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
Cerenovus, Inc. 510(k) NO: K221934(Traditional)
ATTN: Ariell Joner PHONE NO : 908 7269577
6303 Blue Lagoon Drive, Suite 215 SE DECISION MADE: 09-MAR-23
Miami FL 33126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin Pure Pectus System
KLS Martin L.P. 510(k) NO: K221938(Traditional)
ATTN: Melissa Bachorski PHONE NO : 800 6251557
11201 Saint Johns Industrial ParkwSE DECISION MADE: 28-MAR-23
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FemDx FalloView
FemDx Medsystems, Inc. 510(k) NO: K221965(Traditional)
ATTN: PeiJie Cao PHONE NO : 510 3781672
2336 Walsh Avenue Suite A SE DECISION MADE: 17-MAR-23
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InterView XP; InterView FUSION
Mediso Medical Imaging Systems, LT510(k) NO: K221984(Traditional)
ATTN: Daniel Cser PHONE NO : 36 1 3993030
Labore utea 3. SE DECISION MADE: 29-MAR-23
Budapest HU H-1037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gas Insufflator
Surgnova Healthcare Technologies (510(k) NO: K221995(Traditional)
ATTN: Guofang Ma PHONE NO : 86 10 64117355 8108
No.1 Xinxing Yilu Road, Emerging ISE DECISION MADE: 28-MAR-23
Cixi CN 315300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P-Cure Proton Beam Therapy System
P-Cure Ltd. 510(k) NO: K221996(Traditional)
ATTN: Ori Lubin PHONE NO : 972 8 6373030
14 Carmel St. SE DECISION MADE: 20-MAR-23
Shilat IL 7318800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Virtual Implant Positioning (VIP) System
Arthrex Inc. 510(k) NO: K222007(Traditional)
ATTN: Ivette Galmez PHONE NO : 1239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 08-MAR-23
Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPXA-2000
Medipixel, Inc. 510(k) NO: K222036(Traditional)
ATTN: Hye-ri Choi PHONE NO : 82 0 7046990460
Dooam Building 7F, 61, Yangwha-ro,SE DECISION MADE: 22-MAR-23
Seoul KR 04037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endo Ultrasonic Activator
Foshan COXO Medical Instrument Co.510(k) NO: K222096(Traditional)
ATTN: Yongjian Zheng PHONE NO : 86 0757 81800058
BLDG 4,District A Guangdong New LiSE DECISION MADE: 23-MAR-23
Foshan CN 528226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ManaSport+
ManaMed, Inc. 510(k) NO: K222098(Traditional)
ATTN: Trevor Theriot PHONE NO : 940 2873510
5240 W. Charleston Blvd. SE DECISION MADE: 08-MAR-23
Las Vegas NV 89146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prism
GrayMatters Health Ltd. 510(k) NO: K222101(Traditional)
ATTN: Adar Shani PHONE NO : 972 54 2347770
82 Ha’ Atzmaut Street SE DECISION MADE: 17-MAR-23
Haifa IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica® CH Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Inc510(k) NO: K222104(Traditional)
ATTN: Anthony Calabro PHONE NO : 1 609 4336415
500 GBC Drive M/S 514, P.O. Box 61SE DECISION MADE: 20-MAR-23
Newark DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPONSE 5.5/6.0 Cannulated Screw System
OrthoPediatrics Corp. 510(k) NO: K222105(Special)
ATTN: Jennifer Gregory PHONE NO : 574 2670880
2850 Frontier Drive SE DECISION MADE: 23-MAR-23
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comfort Marker 2.0
Medical Precision BV 510(k) NO: K222112(Traditional)
ATTN: Blerta Kukaj PHONE NO :
Telfordstraat 9-30 SE DECISION MADE: 30-MAR-23
Zwolle NL NL 8013 RL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cryo-Thermo Compression Device (FGK002)
Suzhou MicroPort RehabTech (Group)510(k) NO: K222136(Traditional)
ATTN: Liang Hong PHONE NO : 86 1893 6095788
No.112 Fangzhong Rd, Suzhou IndustSE DECISION MADE: 08-MAR-23
Suzhou CN 215002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Endoscopic Hemoclip
Jiangsu Horizon Medical Science & 510(k) NO: K222146(Traditional)
ATTN: Lin Feng PHONE NO : 86 519 69877755
No. 52, Guoxiang Road, Wujin EconoSE DECISION MADE: 28-MAR-23
Changzhou CN 212331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterilization Wrap
Kenpax International Limited 510(k) NO: K222151(Traditional)
ATTN: Jerome Ren PHONE NO : 852 2 2722935
Flat 5, 5/F, Wing On Plaza, 62 ModSE DECISION MADE: 23-MAR-23
Hong Kong CN 999077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadioLens v1.0
Synapsica 510(k) NO: K222174(Traditional)
ATTN: Meenakshi Singh PHONE NO : 91 99 80056517
2591 Dallas Parkway Suite 300 SE DECISION MADE: 28-MAR-23
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BoneView
Gleamer 510(k) NO: K222176(Traditional)
ATTN: Antoine Tournier PHONE NO : 33 615 812345
5 Avenue du Général de Gaulle SE DECISION MADE: 02-MAR-23
Saint Mandé FR 94160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Annalise Enterprise CXR Triage Trauma
Annalise-AI Pty Ltd 510(k) NO: K222179(Traditional)
ATTN: Minta Chen PHONE NO : 61 2 72040817
Level P, 24 Campbell St SE DECISION MADE: 28-MAR-23
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multistage Balloon Dilatation Catheter
Dongguan TT Medical, Inc. 510(k) NO: K222187(Traditional)
ATTN: Yuying Bi PHONE NO : 86 1555 3341910
BLD#1, 1 Taoyuan Road, Songshan LaSE DECISION MADE: 01-MAR-23
Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500
Capenergy Medical S.L. 510(k) NO: K222260(Abbreviated)
ATTN: Pilar Sanchez PHONE NO : 0034 93 4774348___
Avinguda Mare de Déu de MontserratSE DECISION MADE: 28-MAR-23
Sant Joan Despi, Barcelona ES 089510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Annalise Enterprise CXR Triage Trauma
Annalise-AI Pty Ltd 510(k) NO: K222268(Traditional)
ATTN: Minta Chen PHONE NO : 61 2 72040817
Level P, 24 Campbell St SE DECISION MADE: 28-MAR-23
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bigfoot Unity® Diabetes Management System
Bigfoot Biomedical, Inc. 510(k) NO: K222280(Traditional)
ATTN: Kate Lee PHONE NO : 650 2691992
1820 McCarthy Blvd SE DECISION MADE: 01-MAR-23
Milpitas CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RayStation 12A
RaySearch Laboratories AB (publ) 510(k) NO: K222312(Traditional)
ATTN: David Hedfors PHONE NO : 46 8510 53000
Eugeniavagen 18 SE DECISION MADE: 29-MAR-23
Stockholm SE 113 68 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MeMed BV
MeMed Diagnostics Ltd. 510(k) NO: K222332(Traditional)
ATTN: Efrat Hartog-David PHONE NO : 972 4 8500302
Nahum Heth 5 SE DECISION MADE: 23-MAR-23
Tirat Carmel IL 3508504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PathKeeper System
PathKeeper Surgical LTD 510(k) NO: K222355(Traditional)
ATTN: Erez Lampert PHONE NO : 97____ 25 23233038
Hatachana 1, Migdal Menivim floor SE DECISION MADE: 08-MAR-23
Kfar-Saba IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAVE GBR
Dentis Co., Ltd. 510(k) NO: K222367(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 23-MAR-23
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alinity m STI Assay
Abbott Molecular Inc. 510(k) NO: K222379(Traditional)
ATTN: Paul Matushek PHONE NO : 224 3617331
1300 E Touhy Ave SE DECISION MADE: 03-MAR-23
Des Plaines IL 60018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Sphygmomanometers
Qingdao Yasee Medical Device Co., 510(k) NO: K222394(Third Party - Traditional)
ATTN: Shaoju Tian PHONE NO : 86 1334 1254319
No.9 Xiuyuan Road, High-tech IndusSE DECISION MADE: 03-MAR-23
Qingdao CN 266112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KLS Martin Level One Rib Fixation System
KLS-Martin L.P. 510(k) NO: K222397(Traditional)
ATTN: Melissa Bachorski PHONE NO : 800 6251557
11201 Saint Johns Industrial Pkwy SE DECISION MADE: 29-MAR-23
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shina Safety Needle
Shina Corporation 510(k) NO: K222417(Traditional)
ATTN: Seunggi Jeon PHONE NO : 82 41 8530871
8-26, Bojeokdong-gil SE DECISION MADE: 20-MAR-23
Gongju KR 32533 510(k) STATEMENT
DEVICE: Fixone All Suture Anchor
AJU Pharm Co., Ltd. 510(k) NO: K222423(Special)
ATTN: Gun Tak Lee PHONE NO : 82 31 7654420
A-207, 697, Pangyo-ro SE DECISION MADE: 23-MAR-23
Seongnam KR 13511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
bioMerieux SA, Inc. 510(k) NO: K222430(Traditional)
ATTN: Craig Buehler PHONE NO : 314 7318358
595 Anglum Road SE DECISION MADE: 09-MAR-23
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC ChromeFlow
S&C Polymer Silicon- und Composite510(k) NO: K222445(Traditional)
ATTN: Christian Boettcher PHONE NO : 49 0 41214830
Robert-Bosch-Str. 2 SE DECISION MADE: 06-MAR-23
Elmshorn DE 25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
Abbott Diabetes Care Inc. 510(k) NO: K222447(Traditional)
ATTN: Catherine Yang PHONE NO : 510 2069452
1360 South Loop Road SE DECISION MADE: 03-MAR-23
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: High Protection Surgical Gown
3A Medical Products Co., Ltd 510(k) NO: K222456(Traditional)
ATTN: Amy Ma PHONE NO : 86 551 64456982
Yuan Industrial Park SE DECISION MADE: 12-MAR-23
Liuan CN 237100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Provata Implant System
Southern Implants (pty) Ltd 510(k) NO: K222457(Traditional)
ATTN: Leith C Cumming PHONE NO : 27 12 6671046
1 Albert Rd. SE DECISION MADE: 06-MAR-23
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyber Medical Anatomical Plating System
Tyber Medical, LLC 510(k) NO: K222465(Traditional)
ATTN: Lisa Boyle PHONE NO : 610 2957984___
83 South Commerce Way Suite 310 SE DECISION MADE: 07-MAR-23
Bethelehem PA 18017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device
Becton Dickinson and Company 510(k) NO: K222478(Traditional)
ATTN: Katherine Kenner Lemus PHONE NO : 801 5419274
1 Becton Drive SE DECISION MADE: 10-MAR-23
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
IDS, Limited 510(k) NO: K222485(Traditional)
ATTN: K.Y. Ahn PHONE NO : 82 2 20251151 3
194, Simgung-ro, Gwangtan-myeon, PSE DECISION MADE: 29-MAR-23
Gyeonggi-do KR 10952 510(k) STATEMENT
DEVICE: BD BACTEC™ Myco/F Lytic Culture Vials
Becton, Dickinson and Company 510(k) NO: K222559(Traditional)
ATTN: Kamisha Gray PHONE NO : 336 3500948
7 Loveton Circle SE DECISION MADE: 24-MAR-23
Sparks MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: imani i2Plus Breast Pump
imani Co. 510(k) NO: K222573(Traditional)
ATTN: Hyo-Soon Hwang PHONE NO : 82____ 10 99565587
147, Hwasan-ro, Idong-eup, Cheoin-SE DECISION MADE: 03-MAR-23
Yongin-si CN 17135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD BACTEC™ Plus Aerobic/F Culture Vials
Becton, Dickinson and Company 510(k) NO: K222591(Special)
ATTN: Susan Kircher PHONE NO : 410 2599251
7 Loveton Circle SE DECISION MADE: 24-MAR-23
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6F Wallaby Long Sheath
Wallaby Medical Inc 510(k) NO: K222603(Traditional)
ATTN: Nathaniel Knock PHONE NO : 949 4809466
22901 Mill Creek Drive SE DECISION MADE: 02-MAR-23
Laguna Hills CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyTouch Lancing Device
STAT Medical Devices 510(k) NO: K222617(Traditional)
ATTN: Hemel Mariano PHONE NO : 305 9450011 312
2056 N.E. 153rd Street SE DECISION MADE: 21-MAR-23
North Miami Beach FL 33162 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ensmile
Ensmile Pvt Ltd 510(k) NO: K222619(Traditional)
ATTN: Mirza Gohar Rehman PHONE NO : 92 42 111321111
Main Canal RD, No. 2 Block H SE DECISION MADE: 16-MAR-23
Johar Town PK 54000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterilized Latex Surgical Gloves
Suzhou Colour-way New Material Co.510(k) NO: K222620(Traditional)
ATTN: Yongping Xu PHONE NO : 86 512 65371017
No. 20, Anmin Road, Huangdai Town,SE DECISION MADE: 23-MAR-23
Suzhou CN 215152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MultiStage Balloon Dilatation Catheter
Dongguan TT Medical, Inc. 510(k) NO: K222663(Traditional)
ATTN: Yuying Bi PHONE NO : 008 6155 53341910__
BLD#1, 1 Taoyuan Road, Songshan LaSE DECISION MADE: 09-MAR-23
Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Insulin Syringe
Hantech Medical Device Co., Ltd. 510(k) NO: K222672(Traditional)
ATTN: Rachel Jin PHONE NO : 86 1805 8297039
No 288, Sanheng Road Changhe IndusSE DECISION MADE: 06-MAR-23
Ningbo CN 315326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Retraction, CWM-910T, APOLEX Tite
Chungwoo CO., LTD. 510(k) NO: K222709(Traditional)
ATTN: Il Kwon Lee PHONE NO : 82 2 20272200
(Gasan-dong, Woolim Lionsvally-2),SE DECISION MADE: 21-MAR-23
Seoul KR 08591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vial Adapter
Hangzhou Qiantang Longyue Biotechn510(k) NO: K222718(Traditional)
ATTN: Zhengxu Xiang PHONE NO : 137 57329925
302,building 12, building 1,619 WaSE DECISION MADE: 10-MAR-23
Hangzhou CN 311199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrical Scooter, WT-T4QP2
Wu’s Tech Co., Ltd. 510(k) NO: K222729(Traditional)
ATTN: Dr.Jen Ke-Min PHONE NO : 886 3 5382105
No.225, Yuan Peir St. SE DECISION MADE: 28-MAR-23
Hsin-chu City TW 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Overjet Caries Assist
Overjet, Inc. 510(k) NO: K222746(Traditional)
ATTN: Adam Odeh PHONE NO : 817___ 9887697
560 Harrison St., Unit 403 SE DECISION MADE: 27-MAR-23
Boston MA 02118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aarhus Applicator Set
Varian Medical Systems, Inc 510(k) NO: K222775(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
3100 Hansen Way, M/S/E-110 SE DECISION MADE: 13-MAR-23
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
Ecoglove Medical Manufacturing Com510(k) NO: K222813(Traditional)
ATTN: Nguyen Anh Tu PHONE NO : 027 435 99000_____
A Part of Land plot No. 679, map NSE DECISION MADE: 16-MAR-23
Lai Uyen Town, Bau Bang District 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Canon Medical Systems Corporation 510(k) NO: K222819(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 03-MAR-23
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
WickiMed (Huizhou) Medical Equipme510(k) NO: K222828(Traditional)
ATTN: Mac Lai PHONE NO : 0086 0752 3863017
TangJiao XingWang Street, Lilin ToSE DECISION MADE: 20-MAR-23
HuiZhou CN 516003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSyncBrain©-C
iMediSync Inc. 510(k) NO: K222838(Traditional)
ATTN: Young-Geun Kim PHONE NO : 82 10 27765620
3F, 175, Yeoksam-ro, Gangnam-gu SE DECISION MADE: 16-MAR-23
Seoul KR 06247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
Intuitive Surgical Inc 510(k) NO: K222839(Special)
ATTN: Amrit Jaggi PHONE NO : 949 6908799
1266 Kifer Road SE DECISION MADE: 16-MAR-23
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)
3M 510(k) NO: K222859(Traditional)
ATTN: Melanie Avila PHONE NO : 210 2755038
6203 Farinon Drive SE DECISION MADE: 23-MAR-23
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stethophone v1
Sparrow Acoustics Inc. 510(k) NO: K222871(Traditional)
ATTN: Nadezda Ivanova PHONE NO : 1 902 9893908
2416 Natura Dr SE DECISION MADE: 29-MAR-23
Lucasville CA B4B0X3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powered Muscle Stimulator (Model name:MagGraver F200)
Nanjing Vishee Medical Technology 510(k) NO: K222875(Traditional)
ATTN: Kai QIU PHONE NO : 86 025 69670888 8078
Building 9, No. 19, Ningshuang RoaSE DECISION MADE: 09-MAR-23
Nanjing CN 210012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
Endolumik Inc. 510(k) NO: K222880(Traditional)
ATTN: Mara McFadden PHONE NO : 510 4684426
364 Patteson Dr. #293 SE DECISION MADE: 03-MAR-23
Morgantown WV 26505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid NCCT Stroke
iSchemaView, Inc. 510(k) NO: K222884(Traditional)
ATTN: James Rosa PHONE NO : 303 7043374___
1120 Washington Ave., Ste 200 SE DECISION MADE: 02-MAR-23
Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enlight 2100
Timpel S.A. 510(k) NO: K222897(Traditional)
ATTN: Rafael Holtzhacker PHONE NO : 55 11 30880305
R. Simao Alvares, 356 cj. 41/42 - SE DECISION MADE: 07-MAR-23
Sao Paulo BR 05417-020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
Innova Vision Inc. 510(k) NO: K222954(Traditional)
ATTN: Kari Huang PHONE NO : 886 3 5927299
2F., No. 20, Prosperity Rd. 1, HsiSE DECISION MADE: 13-MAR-23
Hsinchu TW 300091 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advantis Platform
Advantis Medical Imaging Single Me510(k) NO: K222975(Traditional)
ATTN: Paris Ziogkas PHONE NO : 30 2109 329558
Eleftheriou Venizelou Avenue 99 NeSE DECISION MADE: 01-MAR-23
Athens GR 17123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroBlate Fusion-S Software V3.17
Monteris Medical, 510(k) NO: K222983(Traditional)
ATTN: David H Mueller PHONE NO : 763___ 3331614
131 Cheshire Lane; suite 100 SE DECISION MADE: 15-MAR-23
Minnetonka MN 55305 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Compression Leg Massager (model: EMK-701)
Xiamen Emoka Health Science & Tech510(k) NO: K222991(Traditional)
ATTN: Iris Fung PHONE NO : 86 185 88874857
D Building, No.100, Jinfu Road, ChSE DECISION MADE: 15-MAR-23
Xiamen CN 361000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0
Canon Medical Systems Corporation 510(k) NO: K223017(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 31-MAR-23
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedCAD AccuPlan System
MedCAD 510(k) NO: K223024(Traditional)
ATTN: Brian Buss PHONE NO : 214 4538864
501 S 2nd Ave, Suite A-1000 SE DECISION MADE: 07-MAR-23
Dallas TX 75226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endo SmartCap
Medivators Inc 510(k) NO: K223040(Special)
ATTN: Disha Kabrawala PHONE NO : 732 3197766
14605 28th Ave North SE DECISION MADE: 01-MAR-23
Minneapolis MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Integrity Spine Core System
Integrity Spine 510(k) NO: K223043(Traditional)
ATTN: Timothy Leak PHONE NO : 512 4966786
414 W Sunset Rd 205 SE DECISION MADE: 20-MAR-23
San Antonio TX 78209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CardioSTAT® ECG Test Solution
Icentia Inc. 510(k) NO: K223049(Traditional)
ATTN: Danièle Grondines PHONE NO : 1 800 4319148 187
2750 Einstein St SE DECISION MADE: 22-MAR-23
Quebec CA G1P4R1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alio
Alio, Inc. 510(k) NO: K223073(Traditional)
ATTN: Kimberly Snyder PHONE NO : 650 6786408
10901 W. 120th Ave, Suite 380 SE DECISION MADE: 17-MAR-23
Broomfield CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Texium™ Closed Male Luer
CareFusion 510(k) NO: K223076(Traditional)
ATTN: Elgin Oktay PHONE NO : 801 3043908
10020 Pacific Mesa Blvd SE DECISION MADE: 24-MAR-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MilkMate Breast Pump
MilkMate Products, Inc. 510(k) NO: K223084(Traditional)
ATTN: Patrice Meagher PHONE NO : 917 6132315
41 Purdy Ave, Box #1052 SE DECISION MADE: 16-MAR-23
Rye NY 10580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceribell Instant EEG Headcap
Ceribell, Inc. 510(k) NO: K223086(Abbreviated)
ATTN: Raymond Woo PHONE NO : 650 5564349
360 N Pastoria Ave SE DECISION MADE: 22-MAR-23
Sunnyville CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senhance Surgical System
Asensus Surgical, Inc. 510(k) NO: K223095(Traditional)
ATTN: Casey Hinckley PHONE NO : 1 801 3105491
1 TW Alexander Drive, Suite 160 SE DECISION MADE: 16-MAR-23
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tegamen Nitrile Examination Gloves
M/S Tegamen Safety Products Privat510(k) NO: K223102(Traditional)
ATTN: Manmohan Gulati PHONE NO : 981 0057779
Sp7-52, Rocco Industrial Area GhilSE DECISION MADE: 15-MAR-23
Alwar CA 301795 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
hearX SA (Pty) Ltd. 510(k) NO: K223137(Traditional)
ATTN: Seline Van Der Wat PHONE NO : 27 12 0300268
Building 2, Ashlea Gardens Office SE DECISION MADE: 14-MAR-23
Pretoria ZA 0081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Galaxy System
Noah Medical Corp. 510(k) NO: K223144(Traditional)
ATTN: Sam Mostafavi PHONE NO : 650 6706972
1501 Industrial Rd. SE DECISION MADE: 01-MAR-23
San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
Magstim Company Ltd. 510(k) NO: K223154(Traditional)
ATTN: Tom Campbell PHONE NO : 440 1994 240798
Spring Gardens SE DECISION MADE: 16-MAR-23
Whitland GB SA340HR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
Healgen Scientific LLC 510(k) NO: K223162(Traditional)
ATTN: Jianqiu Fang PHONE NO : 713 7338088
5213 Maple St SE DECISION MADE: 17-MAR-23
Bellaire TX 77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: lntravascular Administration Sets with Stopcock and Manifold
Baxter Healthcare Corporation 510(k) NO: K223175(Traditional)
ATTN: Meaghan Bonn PHONE NO : 224 2706470
25212 West Illinois Route 120 SE DECISION MADE: 10-MAR-23
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XT Stain/Glaze
Shenzhen Xiangtong Co.,Ltd. 510(k) NO: K223192(Traditional)
ATTN: Xue Gong PHONE NO : 86 137 60477635
2nd Floor, 1st Building, West AreaSE DECISION MADE: 27-MAR-23
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T 24E Posterior Array
Shenzhen RF Tech Co., Ltd. 510(k) NO: K223203(Traditional)
ATTN: Gary Wang PHONE NO : 0086 755 26641989 113
2-F, Bld4, Juhui Industrial Park, SE DECISION MADE: 02-MAR-23
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Procedure mask/Surgical mask/Face mask
Winner Medical Co., Ltd. 510(k) NO: K223232(Traditional)
ATTN: Mingni Liu PHONE NO : 86 755 28138888 8822
Winner Industrial Park, No. 660 BuSE DECISION MADE: 06-MAR-23
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Surgical Face Mask and Medline Procedural Face Mask
Medline Industries, LP 510(k) NO: K223236(Traditional)
ATTN: Kelsey Closen PHONE NO : 847 9492283
Three Lakes Drive SE DECISION MADE: 24-MAR-23
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Colibrí
Copan WASP Srl 510(k) NO: K223245(Traditional)
ATTN: Giovanna Catalano PHONE NO : 39 331 6746551
Via A. Grandi, 32 SE DECISION MADE: 20-MAR-23
Brescia IT 25125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RT Elements (4.0)
Brainlab AG 510(k) NO: K223279(Traditional)
ATTN: Sadwini Suresh PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 14-MAR-23
Munchen DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trevo NXT ProVue Retriever
Stryker Neurovascular 510(k) NO: K223305(Traditional)
ATTN: Heli Chambi PHONE NO : 239 3666826
47900 Bayside Parkway SE DECISION MADE: 29-MAR-23
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnia Medical Coupler-C Anterior Cervical Plate
Omnia Medical, LLC 510(k) NO: K223321(Traditional)
ATTN: Troy Schifano PHONE NO : 304 4134851
6 Canyon Rd SE DECISION MADE: 13-MAR-23
Morgantown WV 26508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Collection Needle (with/without Needle Holder)
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K223323(Traditional)
ATTN: Bingyi Xiang PHONE NO : 86 556 5129666
No. 2 Guanyin Road, Economic DevelSE DECISION MADE: 24-MAR-23
Anqing City CN 246400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMI Panorama
Shanghai United Imaging Healthcare510(k) NO: K223325(Traditional)
ATTN: Xin GAO PHONE NO : 86 21 67076888 5386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 10-MAR-23
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axiom PSR System
Restor3d 510(k) NO: K223326(Traditional)
ATTN: Brianna Prindle PHONE NO : 786 5210501
404 Hunt St. Suite 500 SE DECISION MADE: 30-MAR-23
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
CrossRoads Extremity Systems, LLC 510(k) NO: K223342(Traditional)
ATTN: Kim Strohkirch PHONE NO : 901 6645418
6423 Shelby View Dr., Suite 101 SE DECISION MADE: 30-MAR-23
Memphis TN 38134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Amira; MAGNETOM Sempra
Siemens Medical Solutions USA Inc.510(k) NO: K223343(Traditional)
ATTN: Alina Goodman PHONE NO : 1 224 5261404
40 Liberty Boulevard SE DECISION MADE: 28-MAR-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Remi Robotic Navigation System
Fusion Robotics, LLC 510(k) NO: K223350(Traditional)
ATTN: Sarah Braun PHONE NO : 423 8384454
168 Centennial Parkway Unit 170 SE DECISION MADE: 13-MAR-23
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tenderfoot
Accriva Diagnostics, Inc. 510(k) NO: K223352(Special)
ATTN: Wenni Haley PHONE NO : 858 2632322
6260 Sequence Drive SE DECISION MADE: 02-MAR-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RODIN Palette Naturalizing Kit
Belport Company, Inc., Gingi-Pak 510(k) NO: K223365(Traditional)
ATTN: Jingtian Peng PHONE NO : 909 8390888
4825 Calle Alto SE DECISION MADE: 27-MAR-23
Camarillo CA 93012 510(k) STATEMENT
DEVICE: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Kossan International Sdn Bhd3 510(k) NO: K223375(Traditional)
ATTN: Cho Sow Fong PHONE NO : 603 32910516
Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 15-MAR-23
Klang MY 42100 510(k) STATEMENT
DEVICE: BIASURGE Advanced Surgical Solution
Rochal Technologies LLC 510(k) NO: K223377(Traditional)
ATTN: William Coulston PHONE NO : 210 8706534
1200 Network Boulevard Suite B200 SE DECISION MADE: 30-MAR-23
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iExaminer System with Panoptic Plus
Welch Allyn, Inc. 510(k) NO: K223381(Traditional)
ATTN: Jeffrey E. Thompson PHONE NO : 847 9460902
(a subsidiary of Baxter HealthcareSE DECISION MADE: 15-MAR-23
Skaneateles Falls NY 13153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Wheelchair
Shanghai BangBang Robotics Co., Lt510(k) NO: K223393(Traditional)
ATTN: Canfeng Liu PHONE NO : 086 135 24910052__
Room 501, Building 3, No.188 ZhongSE DECISION MADE: 16-MAR-23
Shanghai CN 201613 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
Xiamen Probtain Medical Techology 510(k) NO: K223401(Traditional)
ATTN: Jianli Kang PHONE NO : 86 592 7557106
4th Floor, No.1 Building, No.6 Ji'SE DECISION MADE: 07-MAR-23
Xiamen CN 361100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeGen Impulse AM™ System
DeGen Medical 510(k) NO: K223418(Traditional)
ATTN: Craig Black PHONE NO : 843 9924551
1321-C North Cashua Drive SE DECISION MADE: 17-MAR-23
Florence SC 29501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triever16 Curve
Inari Medical 510(k) NO: K223419(Special)
ATTN: Ellen Nguyen PHONE NO : 949 4184127
6001 Oak Canyon, Suite 100 SE DECISION MADE: 23-MAR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emory Cardiac Toolbox 4.3
Syntermed 510(k) NO: K223422(Special)
ATTN: Kenneth Van Train PHONE NO : 888 2634446 2
245 South Owens Drive SE DECISION MADE: 30-MAR-23
Anaheim CA 92808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 32HQ713D
LG Electronics Inc. 510(k) NO: K223423(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 8254__ 4690410
168, Suchul-daero SE DECISION MADE: 01-MAR-23
Gumi-si KR 39368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vassallo GT 018 Hybrid
Filmecc CO., LTD 510(k) NO: K223432(Traditional)
ATTN: Toshiya Osawa PHONE NO : 81 52 7681212
1703 Wakita-cho, Moriyama-ku SE DECISION MADE: 09-MAR-23
Nagoya-shi JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Artix AX
Inari Medical 510(k) NO: K223436(Special)
ATTN: Ellen Nguyen PHONE NO : 949 4184127
6001 Oak Canyon, Suite 100 SE DECISION MADE: 02-MAR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
Plasma Concepts 510(k) NO: K223440(Traditional)
ATTN: Brendan Aarons PHONE NO : 617 5195570
800 W Cummings Park SE DECISION MADE: 02-MAR-23
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpaceFlex Acetabular Cup
G21, S.r.l. 510(k) NO: K223441(Traditional)
ATTN: Filippo Foroni PHONE NO : 39 0535 30312
Via Sandro Petrini, 8 SE DECISION MADE: 23-MAR-23
San Possidonio IT 41039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viz AAA
Viz. ai, Inc. 510(k) NO: K223443(Traditional)
ATTN: Pooja Shah PHONE NO : 669 2884344
201 Mission St., 12th Floor SE DECISION MADE: 17-MAR-23
San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitronox Scavenger Plus
Parker Hannifin Corporation 510(k) NO: K223452(Traditional)
ATTN: Dylan Alu PHONE NO : 215 6608132
245 Township Line Road SE DECISION MADE: 05-MAR-23
Hatfield PA 19440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insulin Syringe
Promisemed Hangzhou Meditech Co., 510(k) NO: K223453(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 02-MAR-23
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leg and Foot Air Wave Pressure Therapy Device
Zhangzhou Easepal Innovation Co Lt510(k) NO: K223464(Traditional)
ATTN: Xu Zibing PHONE NO : 13 275 000278
No.36 Longkun Road, Hongjian VillaSE DECISION MADE: 14-MAR-23
Zhangzhou CN 363000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClosureFast™ Endovenous Radiofrequency Ablation Catheter
Medtronic, Inc. 510(k) NO: K223488(Traditional)
ATTN: Aditi Dave PHONE NO : 763 3987029
2300 Berkshire Lane North SE DECISION MADE: 23-MAR-23
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlightPlan for Embolization
GE Medical Systems SCS 510(k) NO: K223490(Traditional)
ATTN: Ning Wen PHONE NO : 33 6 20424417
283, rue de la Miniere SE DECISION MADE: 21-MAR-23
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectral Bone Marrow
GE Medical Systems, LLC 510(k) NO: K223514(Traditional)
ATTN: Katelyn Rowley PHONE NO : 262 3095888
3000 N. Grandview Blvd. SE DECISION MADE: 09-MAR-23
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SonoAir Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., L510(k) NO: K223570(Traditional)
ATTN: Yingying Chen PHONE NO : 0086 510 85311707
No.3 Changjiang South Road, Xinwu SE DECISION MADE: 31-MAR-23
Wuxi CN 214028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solero Microwave Tissue Ablation (MTA) System and Accessories
AngioDynamics, Inc. 510(k) NO: K223581(Special)
ATTN: Kasey E Newcomb PHONE NO : 508 6587813
26 Forest Street SE DECISION MADE: 27-MAR-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Grappler Suture Anchor R3FLEX IOL System
Paragon 28, Inc. 510(k) NO: K223589(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 03-MAR-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
Taiwan Surgical Corporation 510(k) NO: K223593(Traditional)
ATTN: Ken Chen PHONE NO : 886 3 6588129
3F., No. 12, Sec. 2 Sheng Yi Rd. SE DECISION MADE: 22-MAR-23
Zhubei City TW 30261 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Traumatic brain injury (TBI) test
Abbott Laboratories 510(k) NO: K223602(Traditional)
ATTN: Lisa Kelly PHONE NO : 224 6688849
100 Abbott Park Road SE DECISION MADE: 02-MAR-23
Abbott Park IL 60064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RevCore™ Thrombectomy Catheter.
Inari Medical, Inc. 510(k) NO: K223609(Traditional)
ATTN: Suzanne Moreno PHONE NO : 949 6949459
6001 Oak Canyon, Suite 100 SE DECISION MADE: 14-MAR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Calibrate LTX Interbody System
Alphatec Spine, Inc. 510(k) NO: K223611(Traditional)
ATTN: Neha Mohindroo PHONE NO : 760 3566596
1950 Camino Vida Roble SE DECISION MADE: 29-MAR-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InThrill Thrombectomy System
Inari Medical, Inc 510(k) NO: K223613(Traditional)
ATTN: Ellen Nguyen PHONE NO : 1 949 4184127
6001 Oak Canyon, Suite 100 SE DECISION MADE: 17-MAR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CapnoSpot™ Pneumothorax Decompression Indicator
Pneumeric, Inc. 510(k) NO: K223625(Traditional)
ATTN: Johnathon M.E. Aho PHONE NO : 507 2061942
823 4th Street SW, c/o Johnathon ASE DECISION MADE: 28-MAR-23
Rochester MN 55902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEBA® Compact EEG2R Mobile Headset
Neba Health, LLC 510(k) NO: K223628(Traditional)
ATTN: Howard Merry PHONE NO : 706 7365864
2052 Gordon Highway, Ste B. SE DECISION MADE: 02-MAR-23
Augusta GA 30909 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Lip Perfector, model: ZC-05
Light Tree Ventures Europe B.V. 510(k) NO: K223642(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 135 103787481
Laan van Ypenburg 108, 2497 GC, ThSE DECISION MADE: 09-MAR-23
Hague NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Vaginal Panel
Becton, Dickinson and Company 510(k) NO: K223653(Traditional)
ATTN: Joseph Basore PHONE NO : 616 3014068
7 Loveton Circle SE DECISION MADE: 06-MAR-23
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ablacath™ Mapping Catheter
Ablacon, Inc. 510(k) NO: K223666(Traditional)
ATTN: Frank Rodriguez PHONE NO : 401 7225589
4800 Wadsworth Blvd Suite 310 SE DECISION MADE: 17-MAR-23
Wheat Ridge CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instrument Case P1340904
Cochlear 510(k) NO: K223672(Traditional)
ATTN: Denis DiMartino PHONE NO : 508 3044356
10350 Park Meadows Drive SE DECISION MADE: 21-MAR-23
Lone Tree CO 80124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Respiree Cardio-Respiratory Monitor
Respiree PTE Ltd. 510(k) NO: K223681(Traditional)
ATTN: Gurpreet Singh PHONE NO :
115 East Coast Rd SE DECISION MADE: 08-MAR-23
Singapore SG 428804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments
Medos International SÀRL 510(k) NO: K223688(Traditional)
ATTN: Delano Martins PHONE NO : 904 6995797
Chemin-Blanc 38 SE DECISION MADE: 08-MAR-23
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric breast pump (model: M5)
Shenzhen Lutejiacheng Technology C510(k) NO: K223693(Traditional)
ATTN: Athena Pan PHONE NO : 86 0755 84861362
#2-201, Floor 2 Hasee Computer BuiSE DECISION MADE: 09-MAR-23
Shenzhen CN 518129 510(k) STATEMENT
DEVICE: Entasis 3D Dual-Lead Sacroiliac Implant System
CoreLink, LLC 510(k) NO: K223708(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Park SE DECISION MADE: 21-MAR-23
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Precision (TSX-304A/4) V10.14 with AiCE
Canon Medical Systems Corporation 510(k) NO: K223726(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 07-MAR-23
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Ceramic Blocks
Aidite (Qinhuangdao) Technology Co510(k) NO: K223742(Traditional)
ATTN: Chen Yingying PHONE NO : 86____ 15033 560085
No.9 Dushan Road, Economic and TecSE DECISION MADE: 08-MAR-23
Qinhuangdao CN 066000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cervical Plate System
Double Medical Technology Inc. 510(k) NO: K223753(Traditional)
ATTN: Yan Zuo PHONE NO : 86 592 6885068
No. 18, Shanbianhong East Road, HaSE DECISION MADE: 14-MAR-23
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)
Ethicon Endo-Surgery 510(k) NO: K223760(Traditional)
ATTN: Alicia Butler PHONE NO : 513 3374366
475 Calle C SE DECISION MADE: 15-MAR-23
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATEC Lateral Navigation Instruments
Alphatec Spine, Inc. 510(k) NO: K223765(Traditional)
ATTN: Sandy Gill PHONE NO : 1 760 4946633
1950 Camino Vida Roble SE DECISION MADE: 23-MAR-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEEK Spinal Infusion Cage
Changzhou Geasure Medical Apparatu510(k) NO: K223776(Traditional)
ATTN: Jing Huang PHONE NO : 86 136 56146897
No. 12, Jinfeng Road West Taihu ScSE DECISION MADE: 03-MAR-23
Changzhou CN 213149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Hair Removal System (RD-SLD600)
Shanghai Omni Laser Skinology Co.,510(k) NO: K223778(Traditional)
ATTN: Avril Ouyang PHONE NO : 86 021 54847192
Floor 3, Building 3, NO.227, MingqSE DECISION MADE: 31-MAR-23
Shanghai CN 201612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Huvex Interspinous Fusion System
Dio Medical Corp. 510(k) NO: K223790(Traditional)
ATTN: Milan George PHONE NO : 1 877 3945407 102___
2100 Campus Lane, Suite 100 SE DECISION MADE: 09-MAR-23
East Norriton PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
Canary Medical USA LLC 510(k) NO: K223803(Traditional)
ATTN: Kevin Leung PHONE NO : 562 5474067___
2710 Loker Ave. West, Suite 350 SE DECISION MADE: 24-MAR-23
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
Efofex, Inc. 510(k) NO: K223823(Traditional)
ATTN: Siddhant Doshi PHONE NO : 630 2482725
1300 North Dixieland Road SE DECISION MADE: 27-MAR-23
Rogers AR 72756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor Cable (UPN: M004CRBS6600)
Boston Scientific Corporation 510(k) NO: K223824(Traditional)
ATTN: Derek Charchuk PHONE NO : 905 6961913
4100 Hamline Avenue North SE DECISION MADE: 22-MAR-23
St. Paul MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BENCOX Delta Option Heads
Corentec Co., Ltd. 510(k) NO: K223828(Traditional)
ATTN: Yoorim Bae PHONE NO : 82 414 107116
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 16-MAR-23
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRA®-C Integrated Fixation System
Camber Spine Technologies 510(k) NO: K223837(Traditional)
ATTN: Brooks McAdam PHONE NO : 484___ 4277060
501 Allendale Rd SE DECISION MADE: 22-MAR-23
King of Prussia PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)
Thermo Fisher Scientific 510(k) NO: K223844(Traditional)
ATTN: Cynthia Knapp PHONE NO : 1 800 8718909322 4117
One Thermo Fisher Way SE DECISION MADE: 21-MAR-23
Oakwood Village OH 44146 510(k) STATEMENT
DEVICE: Medartis APTUS® Ulna Plates
Medartis AG 510(k) NO: K223853(Traditional)
ATTN: Claudia De Santis PHONE NO : 41 61 6333434___
Hochbergerstrasse 60E SE DECISION MADE: 30-MAR-23
Basel CH CH-4057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBINEURO Alita Intraoperative MRI System
Sino Canada Health Engineering Res510(k) NO: K223875(Traditional)
ATTN: Gong Zhang PHONE NO : 86 1565 6529407
Ltd. (SCHERI) Building B5, NationaSE DECISION MADE: 20-MAR-23
Hefei CN 230088 510(k) STATEMENT
DEVICE: Aevumed RAPID Suture Anchors
Aevumed, Inc. 510(k) NO: K223878(Traditional)
ATTN: Saif Khalil PHONE NO : 610 7457284
109 Great Valley Parkway SE DECISION MADE: 17-MAR-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
Shenzhen Honpal Optoelectronic Tec510(k) NO: K223882(Traditional)
ATTN: Wang Tianming PHONE NO : 86 1598 6705009
Room 505,Shenghui Building A,XixiaSE DECISION MADE: 27-MAR-23
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stativ® Knotted UHMWPE Suture Anchor
Healthium Medtech Limited 510(k) NO: K223889(Traditional)
ATTN: Pankaj Dawar PHONE NO : 91 988 6529934
472-D, 13th Cross, 4th Phase, PeenSE DECISION MADE: 22-MAR-23
Bangalore IN 560058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves
Hebei Titans Hongsen Medical Techn510(k) NO: K223895(Traditional)
ATTN: Xiaojing Shao PHONE NO : 86 133 83292209
Eastern Industrial Zone, Nangong CSE DECISION MADE: 23-MAR-23
Xingtai CN 051800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
Echosens 510(k) NO: K223902(Traditional)
ATTN: Fanny Patoureaux PHONE NO : 33 06 34593671
6 rue Ferrus SE DECISION MADE: 02-MAR-23
Paris FR 75014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tactoset
Anika Therapeutics. Inc. 510(k) NO: K223915(Traditional)
ATTN: Wei Zhao PHONE NO : 978 8885948
32 Wiggins Avenue SE DECISION MADE: 29-MAR-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUMA-G System
CoapTech Inc. 510(k) NO: K223916(Traditional)
ATTN: Jack Kent PHONE NO : 443 5746981
101 W. Dickman Street, Suite 700 SE DECISION MADE: 29-MAR-23
Baltimore MD 21230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOPKINS Telescopes
KARL STORZ Endoscopy-America, Inc 510(k) NO: K223923(Traditional)
ATTN: Alita McElroy PHONE NO : 424 2188376
2151 E. Grand Avenue SE DECISION MADE: 30-MAR-23
EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
Shenzhen Fansizhe Science And Tech510(k) NO: K223928(Traditional)
ATTN: Endang Cheng PHONE NO : 86 186 17061709
2nd, 3rd And 4th Floors, No.11, HeSE DECISION MADE: 28-MAR-23
Shenzhen CN 518125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A1417MCW/A1717MCW/F1417MCW
H&abyz Co., Ltd. 510(k) NO: K223930(Traditional)
ATTN: Jimin Han PHONE NO : 82 70 46589300
1F, 2-Dong, 41-16 Cheoinseong-Ro NSE DECISION MADE: 06-MAR-23
Yongin-Si KR 17118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
Mah Sing Healthcare Sdn Bhd 510(k) NO: K230002(Traditional)
ATTN: Ivan Tan Chee Wei PHONE NO : 603 3396 2288
Wisma Mah Sing, Penthouse Suite 1,SE DECISION MADE: 24-MAR-23
Kuala Lumpur MY 57100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Topzir Biotech Co., Ltd 510(k) NO: K230003(Traditional)
ATTN: Hui Liu PHONE NO : 86 020 32037865
Room 203, Creative Center, No.69, SE DECISION MADE: 31-MAR-23
Guangzhou CN 510663 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ Bond Universal
Meta Biomed Co., LTD. 510(k) NO: K230009(Traditional)
ATTN: Suk Song Oh PHONE NO : 82 43 2308841
270, Osong saengmyeong 1-ro, OsongSE DECISION MADE: 03-MAR-23
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SofWave System
Sofwave Medical Ltd. 510(k) NO: K230019(Traditional)
ATTN: Ruthie Amir PHONE NO : 972 543 003164
1 Ha-Otsma St. SE DECISION MADE: 14-MAR-23
Yokneam Ilit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
Shenzhen Yangyi Technology ., Ltd 510(k) NO: K230021(Traditional)
ATTN: Wang Jie PHONE NO : 86 178 37655793
Third Floor South 201, Building A8SE DECISION MADE: 31-MAR-23
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
Baxter Healthcare Corporation 510(k) NO: K230022(Traditional)
ATTN: Meaghan Bonn PHONE NO : 224 2706470
25212 W. Illinois Route 120 SE DECISION MADE: 31-MAR-23
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SQUALE
Implanet, S.A. 510(k) NO: K230026(Traditional)
ATTN: Régis Le Couëdic PHONE NO : 33 557 995660
Technopole Bordeaux Montesquieu, ASE DECISION MADE: 28-MAR-23
Martillac FR 33650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter Healthcare Corporation 510(k) NO: K230041(Traditional)
ATTN: Meaghan Bonn PHONE NO : 224 2706470
25212 W. Illinois Route 120 SE DECISION MADE: 31-MAR-23
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl examination gloves
Guangdong Kingfa Sci.& Tech.Co., L510(k) NO: K230046(Traditional)
ATTN: Xiaoge Yu PHONE NO : 86 135 70952157
No.28, Delong Avenue, Shijiao TownSE DECISION MADE: 25-MAR-23
Qingyuan CN 511545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSM Biomedical Calcium Phosphate Cement
DSM Biomedical 510(k) NO: K230054(Traditional)
ATTN: Diana Osgood PHONE NO : 484 7132173
735 Pennsylvania Drive SE DECISION MADE: 21-MAR-23
Exton PA 19431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Light Based Hair Removal Device GP592
Shenzhen GSD Tech Co., Ltd. 510(k) NO: K230060(Traditional)
ATTN: Huifang Yao PHONE NO : 86 150 18526594
Building A, JUNSD Hi-Tech Park, WeSE DECISION MADE: 03-MAR-23
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enhanced AURORA™ Medical Diode System, and related accessories
Psoria-Shield, Inc. 510(k) NO: K230076(Traditional)
ATTN: John Yorke PHONE NO : 315 8643465
409 Mandeville St SE DECISION MADE: 08-MAR-23
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable 4 Layers Surgical Face Mask
Social Medical Supply LLC 510(k) NO: K230093(Traditional)
ATTN: Shahzil Amin PHONE NO : 1 214 4169009
11528 Harry Hines Blvd Suite A102 SE DECISION MADE: 02-MAR-23
Dallas TX 75229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Denture Base Resin
Aidite (Qinhuangdao) Technology Co510(k) NO: K230115(Traditional)
ATTN: Chen Yingying PHONE NO : 86 150 33560085
No. 9 Dushan Road, Economic and TeSE DECISION MADE: 17-MAR-23
Qinhuangdao CN 066000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
Light Tree Ventures Europe B.V. 510(k) NO: K230124(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 135 10378748
Laan van Ypenburg 108, 2497 GC, ThSE DECISION MADE: 15-MAR-23
Hague NL 2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOQTEQ® VA Elbow Plates 2.7/3.5 System
aap Implantate AG 510(k) NO: K230141(Traditional)
ATTN: Agnieszka Mierzejewska PHONE NO : 49 30 750190
Lorenzweg 5 SE DECISION MADE: 17-MAR-23
Berlin DE 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epi-Stop Nasal Gel/epistaxis pack
BioMed ENT, Inc. 510(k) NO: K230142(Traditional)
ATTN: Antonius Voermans PHONE NO : 31 0 247114079
18911 Hardy Oak Blvd SE DECISION MADE: 22-MAR-23
San Antonio TX 78258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE-CUF
GE Medical Systems Information Tec510(k) NO: K230145(Traditional)
ATTN: Jennifer Strauther PHONE NO : 262 3302112
9900 W Innovation Dr. SE DECISION MADE: 14-MAR-23
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONLINE TDM Phenytoin - Free Phenytoin application
Roche Diagnostics 510(k) NO: K230161(Traditional)
ATTN: Dr. Leslie Patterson PHONE NO : 317 2258563
9115 Hague Road SE DECISION MADE: 30-MAR-23
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS and EMS Stimulation (OTC)
Changsha Yuwen Medical Equipment C510(k) NO: K230163(Traditional)
ATTN: Chen Dahui PHONE NO : 86 199 73129555
Room 2404, Kairui Building, No. 24SE DECISION MADE: 20-MAR-23
Changsha CN 430103 510(k) STATEMENT
DEVICE: TENS and EMS Stimulation (OTC)
Changsha Yuwen Medical Equipment C510(k) NO: K230174(Traditional)
ATTN: Chen Dahui PHONE NO : 86 199 73129555
Room 2404, Kairui Building, No. 24SE DECISION MADE: 20-MAR-23
Changsha CN 430103 510(k) STATEMENT
DEVICE: Arise™ UHP Dilatation Catheter
Creagh Medical Ltd 510(k) NO: K230191(Traditional)
ATTN: Peter Bather PHONE NO : 952 5007548
IDA Business Park SE DECISION MADE: 22-MAR-23
Ballinasloe IE H53 K8P4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HF Surgery Generator 400KHZ
Richard Wolf Medical Instruments C510(k) NO: K230194(Traditional)
ATTN: Mike McAndrew PHONE NO : 847 9131113
353 Corporate Woods Parkway SE DECISION MADE: 22-MAR-23
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Entarik Feeding Tube System; Entarik Feeding Tube
Gravitas Medical, Inc. 510(k) NO: K230206(Traditional)
ATTN: Saheel Sutaria PHONE NO : 281 7965302
101 Mississippi St SE DECISION MADE: 24-MAR-23
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lyra Influenza A+B Assay
Quidel Corporation 510(k) NO: K230236(Special)
ATTN: Selena Liu PHONE NO : 619 8186642___
10165 McKellar Court SE DECISION MADE: 03-MAR-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx
Shenzhen Bioeasy Biotechnology Co.510(k) NO: K230238(Traditional)
ATTN: Yoyo Lin PHONE NO : 86 755 27948546__
No.2-1,Liuxian 1st Road,Xin'an SubSE DECISION MADE: 31-MAR-23
Shenzhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSA® Knee System
Orthosoft d/b/a Zimmer CAS 510(k) NO: K230243(Traditional)
ATTN: Aura Helena Corredor PHONE NO : 514 4363467
75 Queen Street, Suite 3300 SE DECISION MADE: 29-MAR-23
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
Stryker Sustainability Solutions 510(k) NO: K230251(Special)
ATTN: Scott English PHONE NO : 901 4511456
1810 W Drake Drive SE DECISION MADE: 28-MAR-23
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTRELL™ Mapping Catheter with TRUEref™ Technology
Biosense Webster, Inc. 510(k) NO: K230253(Special)
ATTN: John Jimenez PHONE NO : 949 9234774
31 Technology Drive, Suite 200 SE DECISION MADE: 02-MAR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019
Stryker Sustainability Solutions 510(k) NO: K230255(Special)
ATTN: Scott English PHONE NO : 901 4511456
1810 W Drake Drive SE DECISION MADE: 28-MAR-23
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rebellion, Phantom Multi-Bite Kerrison Rongeur
Morpheus AG 510(k) NO: K230256(Special)
ATTN: Dimitri Krutsch PHONE NO : 49 7424 6099613
Bahnhofstraße 18 SE DECISION MADE: 03-MAR-23
Spaichingen DE 78549 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOLIS Cryoprobe
Varian Medical Systems, Inc. 510(k) NO: K230271(Traditional)
ATTN: Peter J Coronado PHONE NO : 650 4245728
3100 Hansen Way SE DECISION MADE: 28-MAR-23
Palo Alto CA 94304-1038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Diode Laser (M2)
Wuhan Pioon Technology Co.,Ltd. 510(k) NO: K230274(Traditional)
ATTN: Feng Zhang PHONE NO : 86 1806 2448535
7th Floor, A21 of Sino Pharm BuildSE DECISION MADE: 31-MAR-23
Wuhan CN 430075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)
Abbott Medical 510(k) NO: K230283(Special)
ATTN: Chidalu Mozie PHONE NO : 817 2333219
15900 Valley View Court SE DECISION MADE: 01-MAR-23
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoverScan (CoverScan v1.1)
Perspectum 510(k) NO: K230294(Special)
ATTN: Ioan Wigley PHONE NO : 44 186 5655343
Gemini One 5220 John Smith Drive SE DECISION MADE: 03-MAR-23
Oxford GB OX4 2LL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTUNE® Revision Cones
DePuy Ireland UC 510(k) NO: K230295(Traditional)
ATTN: Kathy Boggs PHONE NO : 574 4048711
Loughbeg, Ringaskiddy SE DECISION MADE: 10-MAR-23
Co. Cork Munster IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Athena III Cervical Plate System
Medyssey USA, Inc. 510(k) NO: K230301(Special)
ATTN: Youngsu Jang PHONE NO : 847 4270200
43176 Business Park Dr., Ste. 107 SE DECISION MADE: 07-MAR-23
Temecula CA 92590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuFFRangio Plus
ArteryFlow Technology Co., Ltd. 510(k) NO: K230303(Special)
ATTN: Jianping Xiang PHONE NO : 86 571 86772567
459 Qianmo Road, Suite C1-501, BinSE DECISION MADE: 02-MAR-23
Hangzhou CN 310051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alma Harmony
Alma Lasers, Inc. 510(k) NO: K230308(Traditional)
ATTN: Jessica Rivera Montejo PHONE NO : 224 3772019
485 Half Day Road #100 SE DECISION MADE: 01-MAR-23
Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iris AirShuttle™
Qfix 510(k) NO: K230312(Special)
ATTN: McKenzie Banasik PHONE NO : 610 2680585
440 Church Road SE DECISION MADE: 31-MAR-23
Avondale PA 19311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
Materialise NV 510(k) NO: K230315(Special)
ATTN: Giulia Girola PHONE NO : 32 163 96611
Technologielaan 15 SE DECISION MADE: 06-MAR-23
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Persona™ Personalized Knee System
Zimmer, Inc. 510(k) NO: K230321(Special)
ATTN: Gregory Foster PHONE NO : 574 3710519
1800 W. Center Street SE DECISION MADE: 08-MAR-23
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protrieve Sheath
Inari Medical, Inc. 510(k) NO: K230331(Special)
ATTN: Kaitlyn Weinkauf PHONE NO : 949 4184116
6001 Oak Canyon, Suite 100 SE DECISION MADE: 07-MAR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lyra RSV+hMPV Assay
Quidel Corporation 510(k) NO: K230349(Special)
ATTN: Selena Liu PHONE NO : 619 8186642
10165 McKellar Court SE DECISION MADE: 10-MAR-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aspirex™ Thrombectomy System
C.R. Bard, Inc. 510(k) NO: K230356(Traditional)
ATTN: Aaron Conovaloff PHONE NO : 602 8305453
1625 West 3rd Street SE DECISION MADE: 31-MAR-23
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPS Locator 3D Delivery Catheter
CenterPoint Systems LLC 510(k) NO: K230363(Special)
ATTN: Marybeth Gamber PHONE NO : 774 2495250
3338 Parkway Blvd SE DECISION MADE: 09-MAR-23
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3 Series NeoLux
Daavlin Distributing Co. 510(k) NO: K230382(Special)
ATTN: Michele Thiel PHONE NO : 419 6366304 207
205 West Bement Street SE DECISION MADE: 24-MAR-23
Bryan OH 43506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Savvy Surgical Mask - Level 3
ALG Health LLC 510(k) NO: K230383(Third Party - Traditional)
ATTN: Doug Soper PHONE NO : 419 9906275___
520 W Mulberry St SE DECISION MADE: 06-MAR-23
Bryan OH 43506 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
BioFire Diagnostics, LLC 510(k) NO: K230404(Special)
ATTN: Kevin Bourzac PHONE NO : 801 7366354
515 Colorow Drive SE DECISION MADE: 16-MAR-23
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Knotless FiberTak Suture Anchor
Arthrex Inc. 510(k) NO: K230433(Special)
ATTN: Kelsey Roberts PHONE NO : 239 5984302
1370 Creekside Blvd SE DECISION MADE: 10-MAR-23
Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex 3.9 mm SwiveLock Anchor
Arthrex, Inc. 510(k) NO: K230435(Special)
ATTN: Stacy Valdez PHONE NO : 1 239 6435553
1370 Creekside Boulevard SE DECISION MADE: 17-MAR-23
Naples FL 34113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPOWR Stem Extender, 50mm
Encore Medical, L.P DBA Enovis 510(k) NO: K230441(Special)
ATTN: Thorsen Trey PHONE NO : 850 4503932
9800 Metric Boulevard SE DECISION MADE: 17-MAR-23
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantra Hemostasis Analyzer
HemoSonics, LLC 510(k) NO: K230461(Special)
ATTN: Debbie Winegar PHONE NO : 919 2446990
4020 Stirrup Creek Drive, Suite 10SE DECISION MADE: 24-MAR-23
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
Waldemar Link GmbH & Co. KG 510(k) NO: K230471(Special)
ATTN: Pia Muller PHONE NO : 49 40 53995841__
Barkhausenweg 10 SE DECISION MADE: 21-MAR-23
Hamburg DE 22339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVA5 Insufflator
Palliare Ltd. 510(k) NO: K230474(Special)
ATTN: John O'Dea PHONE NO : 35 391 516362
Galway Business Park, Dangan SE DECISION MADE: 24-MAR-23
Galway IE H91 P2DK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swedge™ Pedicle Screw Fixation System
Spinal Resources, Inc. 510(k) NO: K230482(Special)
ATTN: Bernie Bedor PHONE NO : 904 5409049
5975 N. Federal Highway Suite 250 SE DECISION MADE: 23-MAR-23
Fort Lauderdale FL 33308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
Barco NV 510(k) NO: K230520(Special)
ATTN: Julie Vandecandelaere PHONE NO : 32 562 62319
President Kennedypark 35 SE DECISION MADE: 21-MAR-23
Kortrijk BE 8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WishBone Medical Plate and Screw System
WishBone Medical, Inc. 510(k) NO: K230527(Special)
ATTN: Kayla Johnston PHONE NO : 574 3060328
100 Capital Drive SE DECISION MADE: 29-MAR-23
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Motive™ Electrode
CyMedica Orthopedics, Inc. 510(k) NO: K230533(Third Party - Traditional)
ATTN: Kereshmeh Shahriari PHONE NO : 480 2398553
2120 East 6th Street Suite 8 SE DECISION MADE: 22-MAR-23
Tempe AZ 85288 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Cemented Tibia Baseplate no Taper with JRNY Lock
Smith & Nephew, Inc. 510(k) NO: K230555(Special)
ATTN: Madison Padgett PHONE NO : 901 4568789
7135 Goodlett Farms Parkway SE DECISION MADE: 30-MAR-23
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syngo Carbon Space VA30A
Siemens Healthcare GmBH 510(k) NO: K230561(Third Party - Traditional)
ATTN: Vijay Ramadas PHONE NO : 49 172 4324369
Siemensstr. 1 SE DECISION MADE: 21-MAR-23
Forchheim DE 91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
STERIS Corporation 510(k) NO: K230582(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 28-MAR-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tryptik Ti
Spineart SA 510(k) NO: K230583(Special)
ATTN: Franck Pennesi PHONE NO : 00 412 25701200
3 Chemin du Pre-Fleuri SE DECISION MADE: 22-MAR-23
Plan-les-Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARDO Bellis
ARDO Medical AG 510(k) NO: K230590(Special)
ATTN: Thomas Schlieper PHONE NO : 41 417 547070
Gewerbestrasse 19 SE DECISION MADE: 30-MAR-23
Unteraegeri CH 6314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1788 4K Camera System with Advanced Imaging Modality
Stryker 510(k) NO: K230605(Special)
ATTN: April Malmborg PHONE NO : 408 5742473
5900 Optical Court SE DECISION MADE: 31-MAR-23
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maestro Microcatheter
Merit Medical System, Inc. 510(k) NO: K230636(Special)
ATTN: Garry Courtney PHONE NO : 302 2704789
1600 West Merit Parkway SE DECISION MADE: 30-MAR-23
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartMTA Capsule
Sprig Oral Health Technologies, In510(k) NO: K230797(Third Party - Traditional)
ATTN: Ricky Quintana PHONE NO : 916 6771447
6140 Horseshoe Bar Road SE DECISION MADE: 24-MAR-23
Loomis CA 95650 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 317
TOTAL WITH SUMMARIES 304
TOTAL WITH STATEMENTS 13
