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
