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  1. 510(k) Clearances

January 2020 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2020


DEVICE: ClenchGuard
Boyd Research, Inc.               510(k) NO: K181005(Traditional)
ATTN: James  Boyd                 PHONE NO : 858 3429802 
506 Pacific Ave                   SE DECISION MADE: 15-JAN-20
Solana Beach CA  92075            510(k) STATEMENT
                                                    

DEVICE: SureLead Cable System
Authentic Medical                 510(k) NO: K181089(Traditional)
ATTN: Ricky  Souza                PHONE NO : 916 9526498 
4470 Yankee Hill Rd., Ste 100     SE DECISION MADE: 17-JAN-20
Rocklin CA  95677                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dillard Nasal Balloon Catheter
Intuit Medical Products, LLC      510(k) NO: K181546(Traditional)
ATTN: Jack  Griffis               PHONE NO : 404 5836889 
6018 Eagles Rest Trail            SE DECISION MADE: 03-JAN-20
Sugar Hill GA  30518              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS and EMS Stimulator, TENS Stimulator
Astek Technology Ltd.             510(k) NO: K183074(Traditional)
ATTN: You-Jhe  Lin                PHONE NO : 886 6 2729488 
No. 118 Taizih Rd., Rende Dist    SE DECISION MADE: 11-JAN-20
Tainan City  TW 71741             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Air Next
NuvoAir AB                        510(k) NO: K183089(Traditional)
ATTN: Max  Ladow                  PHONE NO : 46 73 5321442 
17D Riddargatan                   SE DECISION MADE: 02-JAN-20
Stockholm  SE 11457               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruAbutment DS
TruAbutment Inc.                  510(k) NO: K183106(Traditional)
ATTN: Kiyoon  Nam                 PHONE NO : 714 9561488 
17742 Cowan                       SE DECISION MADE: 29-JAN-20
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTRAcel RF Microneedle System
Jeisys Medical Inc.               510(k) NO: K183284(Traditional)
ATTN: Sugun  Lee                  PHONE NO : 82 22603 6417 
307,Daeryung Techno Town 8th, GamaSE DECISION MADE: 15-JAN-20
Seoul  KR 153-775                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNO 30
Genadyne Biotechnologies          510(k) NO: K190028(Traditional)
ATTN: Andrew  Goh                 PHONE NO : 516 4878787 
16 Midland Ave                    SE DECISION MADE: 15-JAN-20
Hicksville NY  11801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VINNO 8, VINNO 6, VINNO 5
VINNO Technology (Suzhou) Co., Ltd510(k) NO: K190120(Traditional)
ATTN: Wei  Wang                   PHONE NO : 86 512 62873806 
5F Building A, 4F Building C No. 2SE DECISION MADE: 23-JAN-20
Suzhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z5-BL
Z-Systems AG                      510(k) NO: K190243(Traditional)
ATTN: Rubino  DiGirolamo          PHONE NO : 41 62 3886969 
Werkhofstrasse 5                  SE DECISION MADE: 03-JAN-20
Oensingen  CH 4702                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FiteBac Cavity Cleanser
Largent Health, LLC               510(k) NO: K190271(Traditional)
ATTN: Kirk  Kimmerling            PHONE NO : 770 2186221 
3698 Largent Way NW, Suite 101    SE DECISION MADE: 23-JAN-20
Marietta GA  30064                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMD Ritmed AssureWear VersaGown
AMD Medicom Inc.                  510(k) NO: K190306(Traditional)
ATTN: Ronald  Reuben              PHONE NO : 514 6366262 
2555 Chemin de l'Aviation         SE DECISION MADE: 17-JAN-20
Pointe-Claire, Montreal  CA H9P 2Z510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Icare ic200
Icare Finland Oy                  510(k) NO: K190316(Traditional)
ATTN: Hannes  Hyvonen             PHONE NO : 358 9 87751150 
Ayritie 22                        SE DECISION MADE: 14-JAN-20
Vantaa  FI 01510                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter
Erbe Elektromedizin GmbH          510(k) NO: K190651(Traditional)
ATTN: Julia  Weller               PHONE NO : 0049 7071 7550 
Waldhoernlestrasse 17             SE DECISION MADE: 07-JAN-20
Tuebingen  DE 72072               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endotics
Era Endoscopy s.r.l.              510(k) NO: K190669(Traditional)
ATTN: Alberto  Arena              PHONE NO : 39 0587 635235 
Via Boccioni, 1                   SE DECISION MADE: 03-JAN-20
Peccioli  IT 56037                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Linshom Respiratory Monitoring Device (LRMD)
Linshom Management LLC            510(k) NO: K190734(Traditional)
ATTN: Ronen  Feldman              PHONE NO : 410 4802700 
2922 Excelsior Springs Court      SE DECISION MADE: 30-JAN-20
Ellicott City MD  21042           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Internal Hex Implant System
EBI Inc.                          510(k) NO: K190837(Traditional)
ATTN: DongJun  Yang               PHONE NO : 82 53 8177767 
124, Uisong-gil, Amnyang-myeon    SE DECISION MADE: 22-JAN-20
Gyeongsan-si  KR 38493            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GammaTile
GT Medical Technologies           510(k) NO: K190839(Traditional)
ATTN: Jessica  Newhard            PHONE NO : 480 2768609 
1809 S Holbrook Lane, Suite 107   SE DECISION MADE: 23-JAN-20
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bio-TackS Orthodontic Mini Implant
Bio Cetec Co., Ltd.               510(k) NO: K190871(Traditional)
ATTN: Hee Sue Jin                 PHONE NO : 82 2 7042876 
RM 1001-1002 New T Castle, 108, GaSE DECISION MADE: 17-JAN-20
Seoul  KR 08506                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
Salter Labs, Inc.                 510(k) NO: K190878(Traditional)
ATTN: Mara  Caler                 PHONE NO : 760 7957094 
2365 Camino Vida Roble            SE DECISION MADE: 10-JAN-20
Carlsbad CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
Ever Growth (Vietnam) Co. Ltd.    510(k) NO: K190942(Abbreviated)
ATTN: Ming  Lee                   PHONE NO : 94 61 3514025 
Long Khanh Industrial Zone BinhlocSE DECISION MADE: 07-JAN-20
Binhloc Village  VN 810000        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fundus Camera
Chongqing Bio NewVision Medical Eq510(k) NO: K190954(Traditional)
ATTN: Wang  Hao                   PHONE NO : 86 136 57617625 
#1-10, F9th, B#4, Group 2N of 2nd SE DECISION MADE: 22-JAN-20
ChongQing  CN 401331              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SCS 17-01
Anika Therapeutics, Inc.          510(k) NO: K190956(Traditional)
ATTN: Jeffrey  Cyr                PHONE NO : 781 4579266 
32 Wiggins Avenue                 SE DECISION MADE: 30-JAN-20
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEX-D2 Posterior Fixation System
Next OrthoSurgical                510(k) NO: K190981(Traditional)
ATTN: Sartaj  Kaur-Hurrle         PHONE NO : 760 2953600 
3270 Corporate View, Suite A      SE DECISION MADE: 15-JAN-20
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elements Viewer
Brainlab AG                       510(k) NO: K191014(Traditional)
ATTN: Oliver  Fleig               PHONE NO : 49 89 9915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 23-JAN-20
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G210 InviCell Plus with SignipHy pH monitoring
CooperSurgical Inc.               510(k) NO: K191020(Traditional)
ATTN: Kyle  Hooper                PHONE NO : 203 6015200 3230
95 Corporate Drive                SE DECISION MADE: 14-JAN-20
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HyaloGYN Vaginal Moisturizing Suppositories
Fidia Farmaceutici S.p.A          510(k) NO: K191052(Traditional)
ATTN: Giuseppina Lo Castro        PHONE NO : 39 04 98232906 
Via Ponte della Fabbrica 3/A      SE DECISION MADE: 09-JAN-20
Abano Terme  IT 35031             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Conformity stem, cemented
United Orthopedic Corporation     510(k) NO: K191056(Traditional)
ATTN: Lois  Ho                    PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park   SE DECISION MADE: 03-JAN-20
Hsinchu City  TW 30075            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optilume Basic Urological Balloon Dilation Catheter
Urotronic Inc                     510(k) NO: K191061(Traditional)
ATTN: David  Perry                PHONE NO : 763 6705247 
2495 Xenium Lane N                SE DECISION MADE: 02-JAN-20
Minneapolis MN  55441             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Isopure Dry Acid Dissolution System
Isopure, Corp.                    510(k) NO: K191093(Traditional)
ATTN: Kevin  Gillespie            PHONE NO : 502 2677873 6672
11851 Plantside Drive             SE DECISION MADE: 22-JAN-20
Louisville KY  40299              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Maxxi Snore Sensor
Neurovirtual USA, INC.            510(k) NO: K191095(Traditional)
ATTN: Eduardo  Faria              PHONE NO : 786 6938200 
3303 W Commercial Blvd #100       SE DECISION MADE: 16-JAN-20
Fort Lauderdale FL  33309         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectra Q
Uzinmedicare Co.                  510(k) NO: K191109(Traditional)
ATTN: Jisun  Lee                  PHONE NO : 82 31 7395271 
Rm 105, Joongang Induspia V, SagimSE DECISION MADE: 22-JAN-20
Seongnam-si  KR 13202             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi-unit Abutments
Medentika GmbH                    510(k) NO: K191123(Traditional)
ATTN: Gerhard  Polzer             PHONE NO : 49 07229 699120 
Hammweg 8-10                      SE DECISION MADE: 06-JAN-20
Hügelsheim  DE 76549              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADAS 3D
Galgo Medical S.L                 510(k) NO: K191125(Traditional)
ATTN: Antoni  Riu                 PHONE NO : 34 93 3283964 
C/Comte d'Urgell, 143, 4B         SE DECISION MADE: 15-JAN-20
Barcelona  ES 08036               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cellvizio 100 Series System with Confocal Miniprobes
Mauna Kea Technologies            510(k) NO: K191144(Traditional)
ATTN: Veronique  Dentan           PHONE NO : 33 17 0080994 
9, Rue d'Enghien                  SE DECISION MADE: 24-JAN-20
Paris  FR 75010                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OC-Auto SENSOR io iFOB Test
Eiken Chemical Co., Ltd.          510(k) NO: K191147(Traditional)
ATTN: Tadashi  Yasuda             PHONE NO : 81 3 58463479 
4-19-9, Taito                     SE DECISION MADE: 02-JAN-20
Taito-ku  JP 110-8408             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARESCAPE B650
GE Healthcare Finland Oy          510(k) NO: K191149(Traditional)
ATTN: Joel  Kent                  PHONE NO : 358 10 39411 
Kuortaneenkatu 2                  SE DECISION MADE: 21-JAN-20
Helsinki  FI FI-00510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
Ad-Tech Medical Instrument Corpora510(k) NO: K191186(Traditional)
ATTN: Lisa  Theama                PHONE NO : 262 6341555 
400 West Oakview Parkway          SE DECISION MADE: 25-JAN-20
Oak Creek WI  53154               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PiccGuard
PiccGuard LLC                     510(k) NO: K191195(Traditional)
ATTN: Katie  Justus               PHONE NO : 918 5192563 
2677 Sarah Lane                   SE DECISION MADE: 03-JAN-20
Beloit WI  53511                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Longeviti ClearFit Cranial Implant
Longeviti Neuro Solutions, LLC    510(k) NO: K191210(Traditional)
ATTN: Jesse  Christopher          PHONE NO : 410 5271803 
303 International Circle Suite 190SE DECISION MADE: 09-JAN-20
Hunt Valley MD  21030             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cybird LED Curing Light
DXM Co., Ltd                      510(k) NO: K191221(Special)
ATTN: Seung Hyun Kim              PHONE NO : 82 31 9098275 
Baekseok-dong, Ilsan technotown 10SE DECISION MADE: 10-JAN-20
Goyang-si  KR 411-360             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paratrooper Plantar Plate Repair System
Paragon 28, Inc.                  510(k) NO: K191227(Traditional)
ATTN: Eric  Lintula               PHONE NO : 888 7281888 
4B Inverness Ct. E, STE 280       SE DECISION MADE: 24-JAN-20
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrapIt
IMDS Operations B.V.              510(k) NO: K191229(Traditional)
ATTN: Edwin  Schulting            PHONE NO : 31 508 200230 
Ceintuurbaan Noord 150            SE DECISION MADE: 21-JAN-20
Roden  NL 9301 Nz                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARESCAPE B450
GE Healthcare Finland Oy          510(k) NO: K191249(Traditional)
ATTN: Joel  Kent                  PHONE NO : 358 10 39411 
Kuortaneenkatu 2                  SE DECISION MADE: 24-JAN-20
Helsinki  FI FI-00510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoClot
EndoClot Plus Co., Ltd.           510(k) NO: K191254(Traditional)
ATTN: Hendry  Zhang               PHONE NO : 086 512 62605550 
101 Room, B8 Building, 218 Xinghu SE DECISION MADE: 30-JAN-20
SuZhou  CN 215000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitalScan ANS
Medeia, Inc.                      510(k) NO: K191266(Traditional)
ATTN: Slav  Danev                 PHONE NO : 800 4334609 
7 W Figueroa Street, Suites 300   SE DECISION MADE: 15-JAN-20
Santa Barbara CA  93101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Proneb Max
PARI Respiratory Equipment, Inc.  510(k) NO: K191270(Traditional)
ATTN: Michael  Judge              PHONE NO : 804 2537274 
2412 PARI Way                     SE DECISION MADE: 23-JAN-20
Midlothian VA  23112              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: All’InCath 035M PTA Balloon Dilatation Catheter
NexStep Medical                   510(k) NO: K191275(Traditional)
ATTN: Angela  Mallery             PHONE NO : 
7-9 Place Saint Bernard           SE DECISION MADE: 15-JAN-20
Dijon  FR 21000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LCCS VC-S RF Cannula
LCCS Products Limited             510(k) NO: K191293(Traditional)
ATTN: Nick  XU                    PHONE NO : 852 82 321050 
Office 3a-7, 12/F, Kaiser Center, SE DECISION MADE: 24-JAN-20
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-EEGX, N-EEGX
GE Healthcare Finland Oy          510(k) NO: K191322(Traditional)
ATTN: Joel  Kent                  PHONE NO : 358 10 39411 
Kuortaneenkatu 2                  SE DECISION MADE: 22-JAN-20
Helsinki  FI FI-00510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carescape B850
GE Healthcare Finland OY          510(k) NO: K191323(Traditional)
ATTN: Joel  Kent                  PHONE NO : 358 10 39411 
Kuortaneenkatu 2                  SE DECISION MADE: 29-JAN-20
Helsinki  FI FI-00510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arc Enterocuff
Boddingtons Plastics Ltd          510(k) NO: K191330(Traditional)
ATTN: Shimaa  Elsawy              PHONE NO : 0044 780 1572833 
Wheelbarrow Park Estate, PattendenSE DECISION MADE: 31-JAN-20
Tonbridge  GB TN12 9QJ            510(k) STATEMENT
                                                    

DEVICE: Quantum® Total Ankle Prosthesis
In2Bones SAS                      510(k) NO: K191380(Traditional)
ATTN: Morgane  Grenier            PHONE NO : 33 4 72292626 
                                  SE DECISION MADE: 29-JAN-20
Ecully  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KardiaMobile, KardiaStation
AliveCor, Inc.                    510(k) NO: K191406(Traditional)
ATTN: Saket  Bhatt                PHONE NO : 650 3968553 
444 Castro Street, Suite 600      SE DECISION MADE: 24-JAN-20
Mountain View CA  94041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hydro-Temp Neonatal Skin Temperature Probe Cover
DeRoyal Industries, Inc.          510(k) NO: K191425(Traditional)
ATTN: Sarah  Bennett              PHONE NO : 865 3626112 
200 DeBusk Lane                   SE DECISION MADE: 21-JAN-20
Powell TN  37849                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cortiQ PRO
g.tec medical engineering GmbH    510(k) NO: K191432(Traditional)
ATTN: Christoph  Guger            PHONE NO : 43 7251 222400 
Sierningerstrasse 14              SE DECISION MADE: 24-JAN-20
Schiedlberg  AT 4521              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ureteral Stent Systems, Biliary Drainage Catheters
Boston Scientific Corporation     510(k) NO: K191446(Traditional)
ATTN: Jois Zuniga Gamboa          PHONE NO : 763 4941588 
300 Boston Scientific Way         SE DECISION MADE: 02-JAN-20
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biopsy Needle
Ushare Medical Inc.               510(k) NO: K191472(Traditional)
ATTN: Yan  Wang                   PHONE NO : 86 756 7516888 
445 An Ji Zhong Road, San Zao TownSE DECISION MADE: 29-JAN-20
Zhuhai  CN 519090                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine 3DP Cervical Interbody System
Genesys Spine                     510(k) NO: K191489(Traditional)
ATTN: Benjamin V. Keller          PHONE NO : 512 3817080 
1250 South Capital of Texas HighwaSE DECISION MADE: 08-JAN-20
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
Cook Incorporated                 510(k) NO: K191498(Traditional)
ATTN: Carly  Powell               PHONE NO : 812 3353575 104913
750 Daniels Way                   SE DECISION MADE: 29-JAN-20
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PALLAS 308/311 Solid-State UV Laser System
Laseroptek Co., Ltd.              510(k) NO: K191501(Special)
ATTN: Hong  Chu                   PHONE NO : 82 31 80235150 
#116, #117, #203, #204 Hyundai I VSE DECISION MADE: 03-JAN-20
Gyeonggido  KR 13212              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Resectr Tissue Resection Device
Boston Scientific Corporation     510(k) NO: K191538(Traditional)
ATTN: Brooke  Cuddy               PHONE NO : 508 6836434 
100 Boston Scientific Way         SE DECISION MADE: 16-JAN-20
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
Rapid Biomedical GmbH             510(k) NO: K191539(Traditional)
ATTN: Christian  Zimmermann       PHONE NO : 49 9365 88260 
Kettelerstrasse 3-11              SE DECISION MADE: 31-JAN-20
Rimpar  DE 97222                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
Titan Spine, Inc                  510(k) NO: K191581(Traditional)
ATTN: Kelly  McDonnell            PHONE NO : 262 2427801 
6140 W. Executive Dr., Suite A    SE DECISION MADE: 08-JAN-20
Mequon WI  53092                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TK Sterile Piston Syringe without Needle
Anhui Tiankang Medical Technology 510(k) NO: K191642(Traditional)
ATTN: Bai  Baodong                PHONE NO : 86 550 7309187 
No.228 Weiyi Road, Economic DeveloSE DECISION MADE: 06-JAN-20
Tianchang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaTap TI Suture Anchor
Medacta International SA          510(k) NO: K191677(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 29-JAN-20
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IP Converter
Sony Electronics Inc.             510(k) NO: K191678(Traditional)
ATTN: Shogo  Obuchi               PHONE NO : 201 3584082 
115 West Century Road, Suite 250  SE DECISION MADE: 10-JAN-20
Paramus NJ  07652                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KardioScreen
iMedrix Inc. (formerly Piitech Inc510(k) NO: K191692(Traditional)
ATTN: Srikanth  Jadcherla         PHONE NO : 1 866 4633749 
1525 McCarthy Blvd., Suite 1059   SE DECISION MADE: 10-JAN-20
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
STERIS Corporation                510(k) NO: K191715(Traditional)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5976 Heisley Road                 SE DECISION MADE: 27-JAN-20
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Route 92 Medical Sheath System
Route 92 Medical Inc.             510(k) NO: K191717(Traditional)
ATTN: Kathy  Tansey               PHONE NO : 408 3916536 
1700 S. El Camino Real, Suite 206 SE DECISION MADE: 13-JAN-20
San Mateo CA  94402               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile LeadConfirm
Alpha Omega Engineering Ltd.      510(k) NO: K191739(Traditional)
ATTN: Maysana  Mousa              PHONE NO : 972 465 63327 
Nazareth Industrial Park, Mount PrSE DECISION MADE: 02-JAN-20
Nazareth  IL 1612102              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electric Breast Pump
Ningbo Huiyoo Baby Products Co. Lt510(k) NO: K191802(Traditional)
ATTN: Xiaoping  Liu               PHONE NO : 86 0574 63679665 
523# Cizhang Road, Zhangqi IndustrSE DECISION MADE: 16-JAN-20
Cixi  CN 315313                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Phantom PT
IBA Dosimetry GmbH                510(k) NO: K191821(Third Party - Abbreviated)
ATTN: Andreas  Suchi              PHONE NO : 49 9128 607943 
Bahnhofstr. 5                     SE DECISION MADE: 23-JAN-20
Schwarzenbruck  DE 90592          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MobiliT Cup
Corin USA Limited                 510(k) NO: K191831(Traditional)
ATTN: Severine  Siracusa          PHONE NO : 813 9774469 
12750 Citrus Park Lane            SE DECISION MADE: 16-JAN-20
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UniSmile Clear Aligner System
Vitang Technology, LLC            510(k) NO: K191837(Traditional)
ATTN: Xiangxu  Chen               PHONE NO : 773 2367691 
14662 Franklin Ave, Unit H        SE DECISION MADE: 29-JAN-20
Tustin CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
VivaLNK, Inc.                     510(k) NO: K191870(Traditional)
ATTN: Quoi V. Huynh               PHONE NO : 408 8682898 
51 E. Campbell Ave. Suite 160     SE DECISION MADE: 07-JAN-20
Campbell CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptoWire III
Opsens Inc.                       510(k) NO: K191907(Traditional)
ATTN: Marc  Chaunet               PHONE NO : 418 7810333 3408
750 Boulevard du Parc TechnologiquSE DECISION MADE: 02-JAN-20
Québec  CA G1P 4S3                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITA VIONIC Bond
VITA Zanhnfabrik H. Rauter GmbH Co510(k) NO: K191926(Traditional)
ATTN: Bernd  Walker               PHONE NO : 49 7761 562361 
Spitelgasse 3                     SE DECISION MADE: 29-JAN-20
Bad Sackingen  DE D-79713         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ezvena IPC, Ezvena SQS
Eezcare Medical Corp              510(k) NO: K191937(Traditional)
ATTN: Michelle C Mitchell         PHONE NO : 757 2240177 
NO.3-1, Minquan St                SE DECISION MADE: 29-JAN-20
New Taipei City 236, Taipei  TW 23510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WVSM (Wireless Vital Signs Monitor) RWC + miniCap
Athena GTX                        510(k) NO: K191989(Traditional)
ATTN: Sean  Mahoney               PHONE NO : 515 2883360 103
5900 NW 86th Street, Suite 300    SE DECISION MADE: 29-JAN-20
Johnston IA  50131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eko Analysis Software
Eko Devices Inc                   510(k) NO: K192004(Traditional)
ATTN: Connor  Landgraf            PHONE NO : 1 844 3563384 
2600 10TH ST,SUITE 260            SE DECISION MADE: 15-JAN-20
Berkeley CA  94710                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LED Curing Light
EZGO Group Inc.                   510(k) NO: K192009(Traditional)
ATTN: Hong  Chen                  PHONE NO : 626 4045522 
8840 Flower Rd 120                SE DECISION MADE: 09-JAN-20
Rancho Cucamonga CA  91730        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYPMHONY™ OCT System
Medos International SARL          510(k) NO: K192014(Traditional)
ATTN: Sheree  Geller              PHONE NO : 508 8283291 
Chemin-Blanc 38                   SE DECISION MADE: 24-JAN-20
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
Advanced Sterilization Products (A510(k) NO: K192025(Traditional)
ATTN: Elsie  Kim                  PHONE NO : 949 9234234 
33 Technology Drive               SE DECISION MADE: 23-JAN-20
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CMOS Video Rhino-Laryngoscope SSU
Karl Storz SE & Co. KG            510(k) NO: K192090(Traditional)
ATTN: Alexey  Davidov             PHONE NO : 49 074 617087909 
Dr.-Karl-Storz-Strasse 34         SE DECISION MADE: 27-JAN-20
Tuttlington  DE 78532             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
Seca GmbH & Co. Kg                510(k) NO: K192092(Traditional)
ATTN: Corinna  Hatje              PHONE NO : 0049 040 200000195 
Hammer Steindamm 3-25             SE DECISION MADE: 23-JAN-20
Hamburg  DE 22089                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzMobile
Ewoosoft Co., Ltd.                510(k) NO: K192098(Traditional)
ATTN: Young Seok Kim              PHONE NO : 82 31 80156172 
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 20-JAN-20
Hwaseong-si  KR 18449             510(k) STATEMENT
                                                    

DEVICE: SABLE Expandable Spacer
Globus Medical Inc.               510(k) NO: K192115(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 14-JAN-20
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V-DENUPET
Vitromed GmbH                     510(k) NO: K192146(Traditional)
ATTN: Deepesh  Changat            PHONE NO : 49 3641 5391976 
Hans-Knöll-Str. 6                 SE DECISION MADE: 28-JAN-20
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FastFit EMS System
Fast Fit LLC                      510(k) NO: K192161(Traditional)
ATTN: Lisa  Falcone               PHONE NO : 212 2884621 
450 Park Avenue 31st Floor        SE DECISION MADE: 22-JAN-20
New York NY  10022                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TTC Phantom® Intramedullary Nail System
Paragon 28, Inc.                  510(k) NO: K192163(Traditional)
ATTN: Haylie  Hertz               PHONE NO : 855 7862828 
14445 Grasslands Dr.              SE DECISION MADE: 31-JAN-20
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VistaScan USB Ultrasound Imaging System
Emagine Solutions Technology, LLC 510(k) NO: K192170(Traditional)
ATTN: Courtney  Williams          PHONE NO : 1 520 4859905 
9040 S. Rita Road, Suite 1270     SE DECISION MADE: 23-JAN-20
Tucson AZ  85747                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C015
Micronica SRL                     510(k) NO: K192182(Traditional)
ATTN: Massimo  Tomasi             PHONE NO : 39 0535 730303 
Via Augusto Righi, 30             SE DECISION MADE: 17-JAN-20
Mirandola  IT 41037               510(k) STATEMENT
                                                    

DEVICE: SoundBite Console, SoundBite Active Wire 18
SoundBite Medical Solution Inc.   510(k) NO: K192211(Traditional)
ATTN: Marc Andre Cote             PHONE NO : 514 9562525 3352
2300 Blvd Alfred Nobel            SE DECISION MADE: 17-JAN-20
Montreal  CA h4S 2A4              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
Invacare Corporation              510(k) NO: K192216(Traditional)
ATTN: Elijah  Wreh                PHONE NO : 440 3266840 
One Invacare Way                  SE DECISION MADE: 02-JAN-20
Elyria OH  44035                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ActiPatch
BioElectronics Corporation        510(k) NO: K192234(Traditional)
ATTN: Sree N. Koneru              PHONE NO : 301 5002061 
4539 Metropolitan Ct              SE DECISION MADE: 31-JAN-20
Frederick MD  21704               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Livento Press, Soprano 10, Soprano
Cendres+Metaux SA                 510(k) NO: K192251(Traditional)
ATTN: Andrea  Sparti              PHONE NO : 41 58360 2000 
rue de Boujean 122                SE DECISION MADE: 15-JAN-20
Biel/Bienne  CH 2501              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
Covidien, llc                     510(k) NO: K192302(Traditional)
ATTN: Carol S Ming                PHONE NO : 508 4521143 
15 Hampshire Street               SE DECISION MADE: 17-JAN-20
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nihon Kohden NKV-550 Series Ventilator System
Nihon Kohden OrangeMed, Inc.      510(k) NO: K192307(Traditional)
ATTN: Sheryl  Higgins             PHONE NO : 949 5026448 7012
1800 E. Wilshire Avenue           SE DECISION MADE: 10-JAN-20
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc.          510(k) NO: K192315(Traditional)
ATTN: Claire  Pigman              PHONE NO : 847 6434071 
Three Lakes Drive                 SE DECISION MADE: 10-JAN-20
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EEA Circular Stapler with Tri-Staple Technology
Covidien                          510(k) NO: K192330(Traditional)
ATTN: Sarah  Tang                 PHONE NO : 86 21 33230158 
Rooms 501, 502, 601, 602, No.3 buiSE DECISION MADE: 23-JAN-20
Min Hang District, Shanghai  CN 20510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Nitrile Examination Gloves Powder Free
JR Engineering & Medical Technolog510(k) NO: K192333(Abbreviated)
ATTN: Ganesan  Sburamaniam        PHONE NO : 603 60 572081 
Lot 8 &10, Jalan Zurah 3 & Lot 1 &SE DECISION MADE: 24-JAN-20
Hulu Selangor  MY 44200           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
Wilson-Cook Medical, Inc.         510(k) NO: K192339(Traditional)
ATTN: Marge  Walls-Walker         PHONE NO : 336 7440157 396290
4900 Bethania Station Road        SE DECISION MADE: 30-JAN-20
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bactisure Wound Lavage
Next Science, LLC                 510(k) NO: K192349(Traditional)
ATTN: Jeanne  Lee                 PHONE NO : 855 5642762 6003
10550 Deerwood Park Blvd., Ste. 30SE DECISION MADE: 23-JAN-20
Jacksonville FL  32256            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INNOVO
Atlantic Therapeutics Ltd.        510(k) NO: K192357(Traditional)
ATTN: Anne-Marie  Keenan          PHONE NO : 353 91 412421 
Parkmore Business Park West       SE DECISION MADE: 16-JAN-20
Galway  IE H91 NHT7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altapore
Baxter Healthcare Corporation     510(k) NO: K192363(Traditional)
ATTN: Phillip  Romei              PHONE NO : 224 9482652 
32650 N. Wilson Road              SE DECISION MADE: 09-JAN-20
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruDi Navigation System
Biosense Webster                  510(k) NO: K192397(Traditional)
ATTN: David  Locke                PHONE NO : 419 2332611 
33 Technology Drive               SE DECISION MADE: 30-JAN-20
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Midwest Rhino XE and Air Motor M
Dentsply Sirona                   510(k) NO: K192409(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 W Philadelphia Street, Suite 6SE DECISION MADE: 13-JAN-20
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
DentalEZ, Inc.                    510(k) NO: K192412(Traditional)
ATTN: Robert  Young               PHONE NO : 717 2911161 
1816 Colonial Village Lane        SE DECISION MADE: 06-JAN-20
Lancaster PA  17601               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Study Watch with Irregular Pulse Monitor
Verily Life Sciences LLC          510(k) NO: K192415(Traditional)
ATTN: Connie  Pascual             PHONE NO : 650 3795200 
269 E Grand Avenue                SE DECISION MADE: 17-JAN-20
South San Francisco CA  94080     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Pain Eraser
Synapse Dental                    510(k) NO: K192429(Traditional)
ATTN: Cosmo  Haralambidis         PHONE NO : 401 9329877 
67 Phenix Avenue                  SE DECISION MADE: 14-JAN-20
Cranston RI  02910                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Healing Abutments and Cover Screws
Dentium Co., Ltd.                 510(k) NO: K192436(Traditional)
ATTN: Byung-sun  Kim              PHONE NO : 82 70 70988806 
150, Eondong-ro Giheung-gu        SE DECISION MADE: 23-JAN-20
Yongin-si  KR 446-914             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wattson Temporary Pacing Guidewire
Vascular Solutions                510(k) NO: K192454(Traditional)
ATTN: Nancy  Frame                PHONE NO : 763 6564230 
6464 Sycamore Court North         SE DECISION MADE: 15-JAN-20
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elos Accurate Customized Abutment
Elos Medtech Pinol A/S            510(k) NO: K192457(Traditional)
ATTN: Tina Friis Poulsen          PHONE NO : 0045 482 16469 
Engvej 33                         SE DECISION MADE: 02-JAN-20
Goerloese  DK DK-3330             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.MR Applications
Siemens Medical Solutions USA Inc.510(k) NO: K192462(Traditional)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
40 Liberty Boulevard, MailCode 65-SE DECISION MADE: 31-JAN-20
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Cathena (TM) Safety IV Catheter
Becton, Dickinson Infusion Therapy510(k) NO: K192493(Traditional)
ATTN: Henry  Boland               PHONE NO : 801 5652550 
9450 South State Street           SE DECISION MADE: 24-JAN-20
Sandy UT  84070                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Black Diamond Navigation Instruments
Osseus Fusion Systems             510(k) NO: K192495(Traditional)
ATTN: Robert  Pace                PHONE NO : 214 3950100 
2703 Mockingbird Lane, Suite 102  SE DECISION MADE: 17-JAN-20
Dallas TX  75235                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOL ha - D Lateral Interbody Fusion System
Cutting Edge Spine, LLC           510(k) NO: K192497(Traditional)
ATTN: Kyle  Kuntz                 PHONE NO : 704 2430892 
101 Waxhaw Professional Park, SuitSE DECISION MADE: 06-JAN-20
Waxhaw NC  28173                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fusion System, Elevate™ Spinal System, Perimeter™ Interbody Fusion Device, Pivox™ Oblique Lateral Spinal System, Sovereign™ Spinal System, T2 Stratosphere™ Expandable Corpectomy System (Cervical and Thoracolumbar)
Medtronic Sofamor Danek USA, Inc  510(k) NO: K192502(Traditional)
ATTN: Emmarie  Halteman           PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 22-JAN-20
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CMOS Video Esophagoscope SSU
Karl Storz SE & Co. KG            510(k) NO: K192523(Traditional)
ATTN: Alexey  Davidov             PHONE NO : 49 07461 7087909 
Dr.-Karl-Storz-StraBe 34          SE DECISION MADE: 24-JAN-20
Tuttlingen  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surefil one Self-adhesive Composite Hybrid
Dentsply Sirona                   510(k) NO: K192530(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 W Philadelphia Street, Suite 6SE DECISION MADE: 23-JAN-20
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
Qinhuangdao Audental Metal Technol510(k) NO: K192535(Traditional)
ATTN: Wang  Xi                    PHONE NO : 86 335 8691916 
Floor 2, 16 North D, 1 Yanghe RoadSE DECISION MADE: 31-JAN-20
Qinhuangdao  CN 066004            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erchonia Emerald
Erchonia Corporation              510(k) NO: K192544(Traditional)
ATTN: Steven  Shanks              PHONE NO : 321 4731251 
650 Atlantis Road                 SE DECISION MADE: 13-JAN-20
Melbourne FL  32904               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGLUMI  2000 HCG/ß-HCG
Shenzhen New Industries Biomedical510(k) NO: K192547(Traditional)
ATTN: Jie  Rao                    PHONE NO : 86 755 21536601 
No.16, Jinhui Road, Pingshan New DSE DECISION MADE: 17-JAN-20
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altera gas Sampling Lines
Meditera Tibbi Malzeme San. ve Tic510(k) NO: K192563(Traditional)
ATTN: Cenk Kilic Kalkan           PHONE NO : 001 902325 135110 177
Ibni Melek OSB Mah. TOSBI Yol 4 SoSE DECISION MADE: 17-JAN-20
Izmir  TR 35900                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Gold Cup EEG Electrodes
Dymedix Diagnostics, Inc.         510(k) NO: K192564(Traditional)
ATTN: Todd  Eiken                 PHONE NO : 888 2121100 
5985 Rice Creek Parkway           SE DECISION MADE: 21-JAN-20
Shoreview MN  55126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The NightBlocks Appliance
Advanced Facialdontics LLC        510(k) NO: K192581(Traditional)
ATTN: Scott  Simonetti            PHONE NO : 631 3793902 
325 Lake Ave. Unit 759            SE DECISION MADE: 28-JAN-20
St James NY  11780                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PicoLazer Laser System
Rohrer Aesthetics, LLC            510(k) NO: K192583(Traditional)
ATTN: Mark  Rohrer                PHONE NO : 205 3561172 
105 Citation Court                SE DECISION MADE: 17-JAN-20
Homewood AL  35209                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
PJM Worldwide, LLC d/b/a Phoenix M510(k) NO: K192585(Special)
ATTN: Ira  Nusbaum                PHONE NO : 305 4772515 
1499 NW 79th Avenue               SE DECISION MADE: 29-JAN-20
Miami FL  33126                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI PTCA Guide Wire ASAHI Gaia Next
Asahi Intecc Co., Ltd.            510(k) NO: K192599(Special)
ATTN: Yasuyuki  Kawahara          PHONE NO : 81 561 561859 
3-100 Akatsuki-cho                SE DECISION MADE: 02-JAN-20
Seto  JP 489-0071                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAC2 - Electrode Cream
Spes Medica S.r.l.                510(k) NO: K192606(Traditional)
ATTN: Giogio  Facco               PHONE NO : 39 082 8614191 
Via Europa - zona industriale     SE DECISION MADE: 17-JAN-20
Battipaglia (SA)  IT 84091        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable SpO2 Sensor
Shenzhen SINO-K Medical Technology510(k) NO: K192608(Traditional)
ATTN: Lao  Chengxin               PHONE NO : 86 137 15333326 
Room401, Bldg2, Veteran Ind. City,SE DECISION MADE: 24-JAN-20
Baoan District, Shenzhen  CN 51800510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
WRP ASIA PACIFIC SDN BHD          510(k) NO: K192635(Traditional)
ATTN: Hasnah Abdul Hamid          PHONE NO : 60 387 061486 
Lot 1, Jalan 3, Kawasan PerusahaanSE DECISION MADE: 17-JAN-20
Sepang  MY 43900                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gemini Titan Sterilization Wrap
Medline Industries, Inc.          510(k) NO: K192641(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 643 3652
Three Lakes Drive                 SE DECISION MADE: 24-JAN-20
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HydroPearl Microspheres
MicroVention, Inc.                510(k) NO: K192684(Traditional)
ATTN: Analia  Staubly             PHONE NO : 714 2478000 2218
35 Enterprise                     SE DECISION MADE: 22-JAN-20
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrellOss™-L MPF
Nexxt Spine LLC                   510(k) NO: K192687(Traditional)
ATTN: Andy  Elsbury               PHONE NO : 317 4367801 
14425 Bergen Blvd, Suite B        SE DECISION MADE: 09-JAN-20
Noblesville IN  46060             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TriMed ASET Foot Plating System
TriMed, Inc.                      510(k) NO: K192696(Traditional)
ATTN: David  Medoff               PHONE NO : 661 2557406 
27533 Avenue Hopkins              SE DECISION MADE: 05-JAN-20
Santa Clarita CA  91355           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRF Radiofrequency Ablation System
Cambridge Interventional LLC      510(k) NO: K192715(Traditional)
ATTN: Michael A. Arnold           PHONE NO : 617 3656899 
78 Cambridge Street               SE DECISION MADE: 07-JAN-20
Burlington MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
Parcus Medical, LLC               510(k) NO: K192750(Traditional)
ATTN: Paul  Vagts                 PHONE NO : 941 7557965 
6423 Parkland Dr                  SE DECISION MADE: 16-JAN-20
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avenger Radial Head System
In2Bones USA, LLC                 510(k) NO: K192754(Traditional)
ATTN: Christine  Scifert          PHONE NO : 901 8318053 
6000 Poplar Ave, Suite 115        SE DECISION MADE: 07-JAN-20
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Asimov-MKS Imaging System
OnLume Inc.                       510(k) NO: K192761(Traditional)
ATTN: Greg  Bange                 PHONE NO : 888 7515131 707
3300 Commercial Ave               SE DECISION MADE: 17-JAN-20
Madison WI  53714                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear Aligner
Royal Dental Lab                  510(k) NO: K192767(Traditional)
ATTN: Mo  Yuyun                   PHONE NO : 86 0755 89501914 
F/1, 2, 3, 5, 6, Building 2, No. 4SE DECISION MADE: 08-JAN-20
Shenzhen  CN 518129               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioCardia 8F Morph DNA Deflectable Guide Catheter
BioCardia                         510(k) NO: K192774(Special)
ATTN: Patrick  Lee                PHONE NO : 650 2260120 
125 Shoreway Road, Suite B        SE DECISION MADE: 07-JAN-20
San Carlos CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Streamline TL Spinal Fixation System
Pioneer Surgical Technology, Inc. 510(k) NO: K192800(Traditional)
ATTN: Kurtis  Hunsberger          PHONE NO : 952 6989931 
375 River Park Circle             SE DECISION MADE: 14-JAN-20
Marquette MI  49855               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quadra-P
Medacta International SA          510(k) NO: K192827(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 06-JAN-20
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CareSens S Clear BT Blood Glucose Monitoring System
i-SENS, Inc.                      510(k) NO: K192859(Special)
ATTN: Joon Ho Jung                PHONE NO : 82 2 9100455 
43, Banpo-daero 28-gil, Seocho-gu SE DECISION MADE: 24-JAN-20
Seoul  KR 06646                   510(k) STATEMENT
                                                    

DEVICE: SherpaPak Lung Preservation System , SherpaPak Liver Transport System
Pragonix Technologies             510(k) NO: K192869(Traditional)
ATTN: Lisa  Anderson              PHONE NO : 617 8177790 
Suite 408, 639 Granite Street     SE DECISION MADE: 16-JAN-20
Braintree MA  02184               510(k) STATEMENT
                                                    

DEVICE: Neo
eemagine Medical Imaging Solutions510(k) NO: K192889(Traditional)
ATTN: Maarten Van De Velde        PHONE NO : 49 030 29048404 
Gubener Str. 47                   SE DECISION MADE: 30-JAN-20
Berlin  DE D-10243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Ceramic Healing Abutments
Institut Straumann AG             510(k) NO: K192893(Traditional)
ATTN: Laure Kuhner Borsenberger   PHONE NO : 41 61 9651389 
Peter Merian Weg 12               SE DECISION MADE: 03-JAN-20
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd          510(k) NO: K192903(Traditional)
ATTN: Ji Yea Lee                  PHONE NO : 82 2 21941594 
3366, Hanseo-ro, Nam-myeon,       SE DECISION MADE: 06-JAN-20
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViewPoint 6
GE Medical Systems Ultrasound and 510(k) NO: K192917(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
Primary Care Diagnostics LLC 9900 SE DECISION MADE: 06-JAN-20
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oragene®•Dx
DNA Genotek Inc.                  510(k) NO: K192920(Traditional)
ATTN: Austin  Udocor              PHONE NO : 1 613 7235757 
3000 - 500 Palladium Drive        SE DECISION MADE: 14-JAN-20
Ottawa  CA K2V 1C2                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RxSight Insertion Device
RxSight, Inc.                     510(k) NO: K192926(Traditional)
ATTN: Maureen  O'Connell          PHONE NO : 978 2071245 
100 Columbia                      SE DECISION MADE: 17-JAN-20
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HySil Super Fast Impression Materials
Osstem Implant Co., Ltd.          510(k) NO: K192941(Traditional)
ATTN: Jungmin  Yoo                PHONE NO : 82 51 8502500 
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 30-JAN-20
Busan  KR 48002                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALLthread Titanium Suture Anchor
Biomet Inc.                       510(k) NO: K192942(Traditional)
ATTN: Saveetha  Raghupathi        PHONE NO : 877 6520830 236
56 East Bell Drive, PO Box 587    SE DECISION MADE: 16-JAN-20
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Auto Positioning
GE Hangwei Medical Systems, Co., L510(k) NO: K192956(Traditional)
ATTN: Yonghui  Han                PHONE NO : 86 10 57083350 
West Area of Building No.3, No.1 YSE DECISION MADE: 16-JAN-20
Beijing  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlowMet
Laser Associated Sciences, Inc.   510(k) NO: K192966(Special)
ATTN: Sean  White                 PHONE NO : 610 7337519 
5171 California Ave., Suite 150   SE DECISION MADE: 10-JAN-20
Irvine CA  92617                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyber Medical Trauma Screw
Tyber Medical LLC                 510(k) NO: K192974(Traditional)
ATTN: Mark  Schenk                PHONE NO : 610 8490645 
83 South Commerce Way, Suite 310  SE DECISION MADE: 08-JAN-20
Bethlehem PA  18017               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyber Medical Trauma Screws
Tyber Medical LLC                 510(k) NO: K192975(Traditional)
ATTN: Mark  Schenk                PHONE NO : 610 8490645 
83 South Commerce Way             SE DECISION MADE: 09-JAN-20
Bethlehem PA  18017               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APTUS Clavicle System
Medartis AG                       510(k) NO: K192984(Traditional)
ATTN: Andrea  Kiefer-Schweizer    PHONE NO : 41 61633 3434 
Hochbergerstrasse 60E             SE DECISION MADE: 24-JAN-20
Basel  CH CH-4057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Glide-On 3G Vinyl Examination Gloves
Medline Industries, Inc.          510(k) NO: K192985(Traditional)
ATTN: Stephanie  Augsburg         PHONE NO : 847 6433960 
Three Lakes Drive                 SE DECISION MADE: 21-JAN-20
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: SCARLET AL-T
Spineart                          510(k) NO: K192993(Traditional)
ATTN: Franck  Pennesi             PHONE NO : 41 2257 01200 
3 Chemin du Pré Fleuri 1228 Plan LSE DECISION MADE: 22-JAN-20
Geneva  CH                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoRemedies Hip Spacer System
OsteoRemedies, LLC                510(k) NO: K192995(Special)
ATTN: Eric  Stookey               PHONE NO : 901 4533141 
6800 Poplar Avenue, #120          SE DECISION MADE: 10-JAN-20
Germantown TN  38138              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
LiNA Medical ApS                  510(k) NO: K193007(Traditional)
ATTN: Jaroslaw  Mrówczynski       PHONE NO : 
Formervangen 5                    SE DECISION MADE: 17-JAN-20
Glostrup  DK 2600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD Horizon™ Fenestrated Screw Set
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K193011(Traditional)
ATTN: Lee  Grant                  PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 10-JAN-20
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL
Thermo Fisher Scientific          510(k) NO: K193024(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 1 800 8718909 
One Thermo Fisher Way             SE DECISION MADE: 08-JAN-20
Oakwood Village OH  44146         510(k) STATEMENT
                                                    

DEVICE: geko™ W-2
Firstkind Limited                 510(k) NO: K193045(Special)
ATTN: Neil  Buckley               PHONE NO : 44 1494 572040 
Hawk House, Peregrine Business ParSE DECISION MADE: 18-JAN-20
High Wycombe  GB HP13 7DL         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
DiaSorin Inc.                     510(k) NO: K193051(Traditional)
ATTN: John C. Walter              PHONE NO : 651 4399710 
1951 Northwestern Ave             SE DECISION MADE: 29-JAN-20
Stillwater MN  55082-0285         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATTUNE All-Polyethylene Tibia
DePuy Ireland UC                  510(k) NO: K193057(Traditional)
ATTN: Kathy Harris Brocato        PHONE NO : 574 3727020 
Loughbeg                          SE DECISION MADE: 30-JAN-20
Ringaskiddy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Noritake Super Porcelain EX-3
Kuraray Noritake Dental Inc.      510(k) NO: K193060(Traditional)
ATTN: Yasujiro  Ohara             PHONE NO : 81 3 67011736 
Ote Center Bldg. 7F               SE DECISION MADE: 30-JAN-20
Chiyoda-ku  JP 100-0004           510(k) STATEMENT
                                                    

DEVICE: TunneLoc Tibial Fixation Device
Biomet Inc.                       510(k) NO: K193092(Traditional)
ATTN: Haley  Pioch                PHONE NO : 412 3762510 214
56 East Bell Drive, PO Box 587    SE DECISION MADE: 02-JAN-20
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anatomical Shoulder System
Zimmer GmbH                       510(k) NO: K193099(Traditional)
ATTN: Roberto  Tommasini          PHONE NO : 41 58 8548264 
Sulzerallee 8                     SE DECISION MADE: 29-JAN-20
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRIaudio PREM System with MRIview
MRIaudio, Inc.                    510(k) NO: K193102(Traditional)
ATTN: Joseph  Caruso              PHONE NO : 858 4270679 
5909 Sea Lion Place, Suite F      SE DECISION MADE: 06-JAN-20
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRCAT brain
Philips Medical Systems MR Finland510(k) NO: K193109(Traditional)
ATTN: Janne  Marvola              PHONE NO : 358 9615800 
Ayritie 4                         SE DECISION MADE: 24-JAN-20
Vantaa  FI 01510                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R2P Destination Slender Guiding Sheath
Terumo Medical Corporation        510(k) NO: K193125(Traditional)
ATTN: Liang  Lu                   PHONE NO : 410 3927321 
950 Elkton Blvd.                  SE DECISION MADE: 06-JAN-20
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EASYGRIP FLO-41 Precision MIS Delivery System
Baxter Healthcare Corportation    510(k) NO: K193137(Traditional)
ATTN: Jeanette  Licata            PHONE NO : 224 9483996 
32650 N. Wilson Road              SE DECISION MADE: 08-JAN-20
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flex Body SPEEDER
Quality Electrodynamics, LLC      510(k) NO: K193140(Traditional)
ATTN: Eric  Yeh                   PHONE NO : 440 4842940 
6655 Beta Drive Suite 100         SE DECISION MADE: 03-JAN-20
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Olympus Medical Systems Corp.     510(k) NO: K193182(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 17-JAN-20
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiiS Horus Eye Anterior Camera
Medimaging Integrated Solution Inc510(k) NO: K193188(Traditional)
ATTN: Yi-Ying  Chen               PHONE NO : 886 3 5798860 1703
3F.,No.24-2, Industry E. Rd. IV, HSE DECISION MADE: 14-JAN-20
Hsinchu  CN 30077                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tamper Evident Cap
International Medical Industries I510(k) NO: K193192(Special)
ATTN: David  Meily                PHONE NO : 954 9179570 227
2981 Gateway Drive                SE DECISION MADE: 31-JAN-20
Pompano Beach FL  33069           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyber Medical Anatomical Plating System
Tyber Medical LLC                 510(k) NO: K193222(Traditional)
ATTN: Mark  Schenk                PHONE NO : 610 8490645 
83 South Commerce Way, Suite 310  SE DECISION MADE: 20-JAN-20
Bethlehem PA  18017               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Persona Personalized Knee System
Zimmer, Inc                       510(k) NO: K193223(Traditional)
ATTN: Gregory  Foster             PHONE NO : 574 3710519 
1800 W. Center Street             SE DECISION MADE: 24-JAN-20
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography
Konica Minolta Healthcare Americas510(k) NO: K193225(Traditional)
ATTN: Jan  Maniscalco             PHONE NO : 800 9341034 1427
2217 US Highway 70 East           SE DECISION MADE: 15-JAN-20
Gamer NC  27529                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MPowRx Snoring Solution (also known as Good Morning Snore Solution)
MPowRx Health and Wellness Product510(k) NO: K193239(Traditional)
ATTN: Nancy  Markley              PHONE NO : 403 6714627 
# 510 3553-31 St. NW              SE DECISION MADE: 03-JAN-20
Calgary  CA T2L2K7                510(k) STATEMENT
                                                    

DEVICE: Emission Computed Tomography System
Shanghai United Imaging Healthcare510(k) NO: K193241(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 21 67076888 6776
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 26-JAN-20
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation       510(k) NO: K193246(Traditional)
ATTN: Rachel  Gilbert             PHONE NO : 781 6473700 1724
200 Prospect Street               SE DECISION MADE: 24-JAN-20
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON Sequia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K193257(Traditional)
ATTN: Sulgue  Choi                PHONE NO : 425 2819898 
685 East Middlefield Road         SE DECISION MADE: 31-JAN-20
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProLift Expandable System
Life Spine Inc.                   510(k) NO: K193258(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 31-JAN-20
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlightPlan for Embolization
GE Medical Systems SCS            510(k) NO: K193261(Traditional)
ATTN: Ning  Wen                   PHONE NO : 33 1 30705668 
283, rue de la Miniere            SE DECISION MADE: 24-JAN-20
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Achieve Catheter Connecting Cable
Innovative Health, LLC.           510(k) NO: K193263(Traditional)
ATTN: Rick  Ferreira              PHONE NO : 877 4003740 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 24-JAN-20
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CapLOX II®/TowerLOX® MIS Pedicle Screw System
Captiva Spine, Inc.               510(k) NO: K193270(Special)
ATTN: George  Chaux               PHONE NO : 877 7725571 
967 N. Alternate A1A Suite 1      SE DECISION MADE: 31-JAN-20
Jupiter FL  33477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Physica LMC Knee System
Limacorporate S.p.A               510(k) NO: K193284(Traditional)
ATTN: Michela  Zanotto            PHONE NO : 39 043 2945511 
Via Nazionale 52                  SE DECISION MADE: 31-JAN-20
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
Parcus Medical, LLC               510(k) NO: K193295(Special)
ATTN: Paul  Vagts                 PHONE NO : 941 7557965 
6423 Parkland Dr                  SE DECISION MADE: 23-JAN-20
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xenocor Articulating Xenoscope Laparoscope
Xenocor, Inc                      510(k) NO: K193315(Special)
ATTN: Evan  Kelso                 PHONE NO : 616 2382988 
630 Komas Dr. Suite 200           SE DECISION MADE: 27-JAN-20
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GTK Veress Needles
Guangzhou T.K Medical Instrument C510(k) NO: K193339(Traditional)
ATTN: Tracy  Weng                 PHONE NO : 86 20322 90169 
A601, Guangzhou International BusiSE DECISION MADE: 30-JAN-20
Guangzhou  CN 510663              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SureMAX Family of Cervical Spacers
Additive Implants, Inc            510(k) NO: K193359(Special)
ATTN: Jeff  Horn                  PHONE NO : 602 7958850 
3101 E. Shea Blvd, Suite 122      SE DECISION MADE: 03-JAN-20
Phoenix AZ  85028                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
Radmedix LLC                      510(k) NO: K193360(Traditional)
ATTN: Gabriel  Issa               PHONE NO : 
2510 Lance Dr.                    SE DECISION MADE: 02-JAN-20
Dayton OH  45409                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Pedicle Screw System
Medacta International SA          510(k) NO: K193365(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 27-JAN-20
Castel San Pietro  CH ch-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexxt Matrixx System
Nexxt Spine LLC                   510(k) NO: K193370(Special)
ATTN: Andy  Elsbury               PHONE NO : 317 4367801 
14425 Bergen Blvd, Suite B        SE DECISION MADE: 21-JAN-20
Noblesville IN  46060             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Univers Revers Modular Glenoid System (Augemented baseplates)
Arthrex Inc.                      510(k) NO: K193372(Special)
ATTN: Ivette  Galmez              PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 10-JAN-20
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroBlate System
Monteris Medical                  510(k) NO: K193375(Special)
ATTN: David H. Mueller            PHONE NO : 763 2534710 
14755 27th Avenue North; Suite C  SE DECISION MADE: 03-JAN-20
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlignRT Plus
Vision RT Ltd                     510(k) NO: K193431(Special)
ATTN: Arun  Mahendran             PHONE NO : 44 773 7637807 
Dove House, Arcadia Avenue        SE DECISION MADE: 03-JAN-20
London  GB N3 2JU                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMIStem-C
Medacta International SA          510(k) NO: K193433(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 09-JAN-20
Castel San Pietro  CH cH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ER-REBOA PLUS Catheter
Prytime Medical Devices, Inc      510(k) NO: K193440(Special)
ATTN: Brian  Young                PHONE NO : 210 2163020 
229 North Main Street             SE DECISION MADE: 09-JAN-20
Boerne TX  78006                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MotoBAND CP Implant System
CrossRoads Extemity Systems, LLC  510(k) NO: K193452(Special)
ATTN: Kim  Strohkirch             PHONE NO : 901 2218406 
6055 Primacy Pkwy, Suite 140      SE DECISION MADE: 10-JAN-20
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IQon Spectral CT
Philips Medical Systems, Nederland510(k) NO: K193454(Traditional)
ATTN: Nimit  Shah                 PHONE NO : 1 440 8694409 
Veenpluis 4-6                     SE DECISION MADE: 24-JAN-20
Best  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorticaLINK Spinal Fusion Platform
Spine Smith Holdings, LLC         510(k) NO: K193465(Special)
ATTN: Nickolas G. Kriska          PHONE NO : 512 6376745 
4719 South Congress Ave.          SE DECISION MADE: 10-JAN-20
Austin TX  78745                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XTRAC Momentum Excimer Laser System
Strata Skin Sciences, Inc.        510(k) NO: K193478(Special)
ATTN: Chuck  Mierkiewicz          PHONE NO : 760 6023300 
5 Walnut Grove Drive, Suite 140   SE DECISION MADE: 14-JAN-20
Horsham PA  19044                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOEASY Multi-Drug Test Cup
Shenzhen Bioeasy Biotechnology Co.510(k) NO: K193480(Traditional)
ATTN: Wenhau  Yan                 PHONE NO : 86 755279 48546 
No.2-1, Liuxian 1st Road, Xin'an SSE DECISION MADE: 31-JAN-20
Shenzhen  CN 518101               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GlideScope BFlex 3.8 Single-Use Bronchoscope
Verathon Medical (Canada) ULC     510(k) NO: K193488(Special)
ATTN: Teresa  Davidson            PHONE NO : 425 6295516 
2227 Douglas Road                 SE DECISION MADE: 16-JAN-20
Burnaby  CA V5C 5A9               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Total IgE (tIgE)
Siemens Healthcare Diagnostics Inc510(k) NO: K193493(Traditional)
ATTN: Ian  Thompson               PHONE NO : 914 5242296 
511 Benedict Avenue               SE DECISION MADE: 15-JAN-20
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stellar M22 for Intense Pulsed Light (IPL) and Laser System
Lumenis Ltd.                      510(k) NO: K193500(Special)
ATTN: Shlomit  Segman             PHONE NO : 972 4 9599085 
6 Hakidma Street PO Box 240       SE DECISION MADE: 16-JAN-20
Yokneam  IL 2069204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex SwiveLock Suture Anchor
Arthrex Inc.                      510(k) NO: K193503(Special)
ATTN: Jessica L. Singelais        PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard          SE DECISION MADE: 15-JAN-20
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyDisk AST Cefiderocol 30ug (FDC30)
Hardy Diagnostics                 510(k) NO: K193504(Traditional)
ATTN: Rianna  Malherbe            PHONE NO : 800 2662222 5714
1430 West McCoy Lane              SE DECISION MADE: 23-JAN-20
Santa Maria CA  93455             510(k) STATEMENT
                                                    

DEVICE: Merit ONE Snare System
Merit Medical Systems, Inc.       510(k) NO: K193507(Special)
ATTN: Mark  Mullaney              PHONE NO : 35 3917 03700 3061
Parkmore Business Park West       SE DECISION MADE: 17-JAN-20
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
Acutus Medical, Inc.              510(k) NO: K193509(Third Party - Traditional)
ATTN: Greg  Geissinger            PHONE NO : 1 442 2326128 
2210 Faraday Ave, Suite 100       SE DECISION MADE: 17-JAN-20
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Terason uSmart3200T Ultrasound System
Teratech Corporation              510(k) NO: K193510(Third Party - Traditional)
ATTN: Steven R. Broadstone        PHONE NO : 
77-79 Terrace Hall Ave.           SE DECISION MADE: 28-JAN-20
Burlington MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: THD Procto Software System
THD SpA                           510(k) NO: K193512(Traditional)
ATTN: Filippo  Bastia             PHONE NO : 39 0522 634311 
Via dell'Industria, 1             SE DECISION MADE: 26-JAN-20
Correggio  IT 42015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System
In2Bones USA, LLC                 510(k) NO: K193543(Special)
ATTN: Christine  Scifert          PHONE NO : 901 8318053 
6000 Poplar Ave, Suite 115        SE DECISION MADE: 17-JAN-20
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CustomizedBone Service
Fin-Ceramica Faenza Spa           510(k) NO: K193547(Special)
ATTN: Marina  Monticelli          PHONE NO : 0039 05466 07311 
Via Ravegnana 186                 SE DECISION MADE: 17-JAN-20
Faenza  IT 48018                  510(k) STATEMENT
                                                    

DEVICE: Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K193548(Special)
ATTN: Ryan  Kenney                PHONE NO : 949 5684169 
9775 Toledo Way                   SE DECISION MADE: 18-JAN-20
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZELTIQ CoolSculpting System
ZELTIQ Aesthetics, Inc.           510(k) NO: K193566(Special)
ATTN: Tammy  Wharton              PHONE NO : 571 7582123 
4410 Rosewood Drive               SE DECISION MADE: 21-JAN-20
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIVO(TM)
Velano Vascular                   510(k) NO: K193569(Special)
ATTN: Tiffini  Wittwer            PHONE NO : 707 7996732 
221 Pine St #200                  SE DECISION MADE: 21-JAN-20
San Francisco CA  94104           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Pain Eraser
Synapse Dental                    510(k) NO: K193570(Special)
ATTN: Cosmo  Haralambidis         PHONE NO : 401 9329877 
67 Phenix Avenue                  SE DECISION MADE: 17-JAN-20
Cranston RI  02920                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q-Rad System
Carestream Health, Inc.           510(k) NO: K193574(Special)
ATTN: Carolyn L Wagner            PHONE NO : 585 6276588 
Building 7, No. 1510 Chuanqiao RoaSE DECISION MADE: 22-JAN-20
China (Shanghai) Pilot Free Trade 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CareSens S Fit BT Blood Glucose Monitoring System
i-SENS, Inc.                      510(k) NO: K193590(Special)
ATTN: Joon Ho Jung                PHONE NO : 82 2 9100453 
43, Banpo-daero 28-gil, Seocho-gu SE DECISION MADE: 17-JAN-20
Seoul  KR 06646                   510(k) STATEMENT
                                                    

DEVICE: Y-Knot OneStep Anchor
ConMed Corporation                510(k) NO: K193606(Special)
ATTN: Carrie  Engleman            PHONE NO : 727 3995574 
525 French Road                   SE DECISION MADE: 22-JAN-20
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viveve 2.0 System
Viveve Medical, Inc.              510(k) NO: K193611(Special)
ATTN: Kevin  Robison              PHONE NO : 317 4358898 
345 Inverness Drive South, BuildinSE DECISION MADE: 16-JAN-20
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System
Compania Mexicana De Radiologia CG510(k) NO: K193637(Special)
ATTN: Tonatiuh Monroy Soberon     PHONE NO : 55 548 21300 
Fraccionamiento Industrial la NoriSE DECISION MADE: 28-JAN-20
El Marques, Queretaro  MX 76240   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
Dexcom, Inc.                      510(k) NO: K193642(Special)
ATTN: Linda  Wang                 PHONE NO : 858 2036816 
6340 Sequence Drive               SE DECISION MADE: 29-JAN-20
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: nva, nvp, and nvt
Nvision Biomedical Technologies, I510(k) NO: K193645(Special)
ATTN: Diana  Langham              PHONE NO : 210 5453713 
4590 Lockhill Selma               SE DECISION MADE: 13-JAN-20
San Antonio TX  78429             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAD1717MC
H&abyz                            510(k) NO: K200018(Traditional)
ATTN: Nam Kyu Hur                 PHONE NO : 82 70 46589306 
1F, 2-dong, 41-16, Cheoinseong-ro,SE DECISION MADE: 31-JAN-20
Yongin-si  KR 17118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    


                 TOTAL 510(k)s THIS PERIOD   232                                     
                 TOTAL WITH SUMMARIES        219                                     
                 TOTAL WITH STATEMENTS        13