510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2019
DEVICE: Maxxi Rip Sensor
Neurovirtual USA, INC. 510(k) NO: K171304(Traditional)
ATTN: Eduardo Faria PHONE NO : 786 6938200
2315 NW 107th Ave Suite# 1M27 SE DECISION MADE: 24-JUN-19
Doral FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
AMS Diagnostics 510(k) NO: K172232(Traditional)
ATTN: Samuel Burgos PHONE NO : 954 2170040 302
1790 N Commerce Parkway SE DECISION MADE: 12-JUN-19
Weston FL 33326 510(k) STATEMENT
DEVICE: eon
Dominion Aesthetic Technologies, I510(k) NO: K180511(Traditional)
ATTN: Ahmed Mohammed PHONE NO : 763 4394602
2431 Aloma Avenue Suite # 225 SE DECISION MADE: 12-JUN-19
Winter Park FL 32792 510(k) STATEMENT
DEVICE: MINE
RHT Co., Ltd 510(k) NO: K180671(Traditional)
ATTN: Joon-Ho Oh PHONE NO : 82 62 4317752
207, cheomdangwagiro, 208 bungil 5SE DECISION MADE: 05-JUN-19
Gwangju KR 61012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceramic Bracket
MEM Dental Technology Co., Ltd 510(k) NO: K180952(Traditional)
ATTN: Anita Chen PHONE NO : 886 0 939855759
2F., No.22, Ln.31, Sec.1, HuandongSE DECISION MADE: 07-JUN-19
Tainan City TW 74146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiiS Horus Scope DPT 100
Medimaging Integrated Solution Inc510(k) NO: K181260(Traditional)
ATTN: Chih-Lu Hsu PHONE NO : 886 3 5798860 1110
1F, No.7, R&D Rd. II Hsinchu ScienSE DECISION MADE: 21-JUN-19
Hsinchu CN 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeraQuest HSV Type 2 Specific IgG
Quest International, Inc. 510(k) NO: K181514(Traditional)
ATTN: Steve Andrus PHONE NO : 772 2836540
1935 SW Martin Highway SE DECISION MADE: 13-JUN-19
Palm City FL 34990 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SureTouch Mobile Pressure Mappring System
Sure Inc. 510(k) NO: K181672(Traditional)
ATTN: David Ables PHONE NO : 310 7019509
1404 Granvia Altamira SE DECISION MADE: 28-JUN-19
Palos Verdes Estates CA 90274 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Restore Toothpaste
Dr. Collins, Inc. 510(k) NO: K181965(Traditional)
ATTN: Jiahe Li PHONE NO : 949 5526334
4330 Barranca Pkwy. Ste #100 SE DECISION MADE: 13-JUN-19
Irvine CA 92604 510(k) STATEMENT
DEVICE: AXTi Titanium Stand-Alone ALIF System
Innovasis, Inc. 510(k) NO: K182139(Traditional)
ATTN: Marshall McCarty PHONE NO : 801 2612236
614 East 3900 South SE DECISION MADE: 21-JUN-19
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: tün® ultrasonic tips product family
Engineered Endodontics 510(k) NO: K182145(Traditional)
ATTN: Mark Fiorina PHONE NO : 262 501 0075
W134 N4965 Campbell Drive SE DECISION MADE: 07-JUN-19
Menomonee Falls WI 53051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Strome-Blitzer Cytology Balloon
ADN International LLC 510(k) NO: K182159(Traditional)
ATTN: Marshall Strome PHONE NO : 917 7032517
425 West 59th Street SE DECISION MADE: 13-JUN-19
New York NY 10019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PK High Tibial Osteotomy Correction System
Paonan Biotech Co., Ltd. 510(k) NO: K182285(Traditional)
ATTN: Vivi Tsai PHONE NO : 886 2 26274366
3F, No. 50, Lane. 258, Rueiguang RSE DECISION MADE: 20-JUN-19
Taipei City TW 11491 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scooter, Model: R-100
Yongkang Dingchang Industry & Trad510(k) NO: K182411(Traditional)
ATTN: Cheng Chen PHONE NO : 86 579 87128717
No99, HuaxiRoad, Xicheng Street SE DECISION MADE: 24-JUN-19
Yongkang CN 321300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA Minimally Invasive System
BAUI Biotech CO., LTD. 510(k) NO: K182416(Abbreviated)
ATTN: Herman Jhan PHONE NO : 8862 8976 9538 154
6F., No.8, Sec. 1, Zhongxing Rd., SE DECISION MADE: 11-JUN-19
New Taipei City TW 24872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo O3 Regional Oximeter System
Masimo Corporation 510(k) NO: K182429(Traditional)
ATTN: Sindura Penubarthi PHONE NO : 949 2977592
52 Discovery SE DECISION MADE: 07-JUN-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bovine Pericardial Tissue Patch
Tisgenx 510(k) NO: K182493(Traditional)
ATTN: Kris Kupumbati PHONE NO : 949 3157157
15615 Alton Parkway, Suite 450 SE DECISION MADE: 18-JUN-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
Physio-Control, Inc. 510(k) NO: K182503(Traditional)
ATTN: Chelsea Cullen PHONE NO : 1 425 8674138
11811 Willow Road NE SE DECISION MADE: 03-JUN-19
Redmond WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Miha Bodytec II
Miha Bodytec Gmbh 510(k) NO: K182519(Traditional)
ATTN: Juergen Decker PHONE NO : 49 821 4554920
Siemensstr. 1 SE DECISION MADE: 07-JUN-19
Gersthofen DE 86368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALILEO Spine Alignment Monitoring System
MiRus, LLC 510(k) NO: K182524(Traditional)
ATTN: Jordan Bauman PHONE NO : 678 3246272
2150 Newmarket Parkway Suite 108 SE DECISION MADE: 17-JUN-19
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hailie Sensor
Adherium (NZ) Ltd 510(k) NO: K182573(Traditional)
ATTN: Chris Mander PHONE NO : 64 9 3072771
Level 2, 204 Quay Street SE DECISION MADE: 07-JUN-19
Auckland NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oyster ACIF Cage
Silony Medical GmbH 510(k) NO: K182608(Traditional)
ATTN: Bircan Tasdelen PHONE NO : 49 711 78252540
Leinfelder Straße 60 SE DECISION MADE: 13-JUN-19
Leinfelden-Echterdingen DE d-7077510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diapex Plus
Diadent Group International 510(k) NO: K182625(Traditional)
ATTN: Myung sub Kim PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 03-JUN-19
Cheongji-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hailie Sensor
Adherium (NZ) Ltd 510(k) NO: K182638(Traditional)
ATTN: Chris Mander PHONE NO : 64 9307 2771
Level 2, 204 Quay Street SE DECISION MADE: 19-JUN-19
Auckland NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arzzt Distal Radius and Ulna System
Truemed Group LLC 510(k) NO: K182650(Traditional)
ATTN: Nina Galeana Rodriguez PHONE NO : 1 832 4422310
2002 Timberloch Place Suite 200 SE DECISION MADE: 10-JUN-19
The Woodlands TX 77380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAMBRO Single Core A Sterilization wrap
Jiangsu Zhande Medical Supplies Co510(k) NO: K182656(Traditional)
ATTN: Chanjuan Xu PHONE NO : 01186 25 52360731
Nanjing Binjiang Economic DevelopmSE DECISION MADE: 11-JUN-19
Nanjing CN 211178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bioliner
Five Star Orthodontic Lab & Supply510(k) NO: K182658(Traditional)
ATTN: Andrew Loch PHONE NO : 800 5212351
2928 Metro Street, Suite 102 SE DECISION MADE: 19-JUN-19
Denton TX 76207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Med-link Temperature Probes
Shenzhen Med-link Electronics Tech510(k) NO: K182667(Traditional)
ATTN: Baihan Feng PHONE NO : 0086 755 61568825 833
4th Fl, Bldg A, Yingtailong IndustSE DECISION MADE: 18-JUN-19
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-Robot Patient Positioning System
Chinan Biomedical Technology, Inc.510(k) NO: K182683(Traditional)
ATTN: James Chinan Chen PHONE NO : 886 3 5509118
6F., No.16, Sec.2 , Shengyi Rd., ZSE DECISION MADE: 27-JUN-19
Hsinchu County TW 302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
Cook Incorporated 510(k) NO: K182695(Traditional)
ATTN: Chelsea Woods PHONE NO : 812 3392235 104707
750 Daniels Way SE DECISION MADE: 17-JUN-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EntericBio Dx Assay
Serosep, Ltd. 510(k) NO: K182703(Traditional)
ATTN: David Clancy PHONE NO : 353 61 358190
Annacotty Business Park SE DECISION MADE: 19-JUN-19
Annacotty IE V94 FF83 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WishBone Guided Growth System
WishBone Medical 510(k) NO: K182704(Traditional)
ATTN: Gary Barnett PHONE NO : 574 3064006
1250 North Pointe Drive SE DECISION MADE: 25-JUN-19
Warsaw IN 46992 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scoreflex PTA Scoring Balloon Catheter
OrbusNeich Medical Trading, Inc. 510(k) NO: K182713(Traditional)
ATTN: John Pazienza PHONE NO : 954 7300711
5363 NW 35th Avenue SE DECISION MADE: 11-JUN-19
Fort Lauderdale FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
Quidel Cardiovascular Inc. 510(k) NO: K182719(Traditional)
ATTN: Rachael S. Williamson PHONE NO : 858 3020334
9975 Summers Ridge Road SE DECISION MADE: 19-JUN-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rochal Bioshield Silicone Film
Rochal Industries, LLC 510(k) NO: K182733(Traditional)
ATTN: William J. Coulston PHONE NO : 210 3759349
12000 Network Blvd, Ste B200 SE DECISION MADE: 27-JUN-19
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DB-CMF
Dimensional Bioceramics, LLC 510(k) NO: K182742(Traditional)
ATTN: Duran N. Yetkinler PHONE NO : 408 7576603
250 Natural Bridges Drive SE DECISION MADE: 20-JUN-19
Santa Cruz CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
Lansinoh Laboratories Saglik Gerec510(k) NO: K182749(Traditional)
ATTN: Lindsay Ewers PHONE NO : 703 2606963
Sti. 10006 sok. No: 64 AOSB SE DECISION MADE: 12-JUN-19
Cigli TR 35620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOP U (Packed Black USA), STOP U (Packed White USA)
Pollogen Ltd. 510(k) NO: K182774(Traditional)
ATTN: Einat Shammai PHONE NO : 972 52 300142
6 Kaufman St. SE DECISION MADE: 19-JUN-19
Tel Aviv IL 6801298 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOQTEQ VA Foot Plates 2.5
aap Implantate AG 510(k) NO: K182785(Traditional)
ATTN: Annesha Lahiri PHONE NO : 0049 30 75019193
Lorenzweg 5 SE DECISION MADE: 19-JUN-19
Berlin DE D-12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
Cook Incorporated 510(k) NO: K182832(Traditional)
ATTN: Kotei Aoki PHONE NO : 812 3353575 102630
750 Daniels Way SE DECISION MADE: 26-JUN-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI SASUKE
Asahi Intecc Co., Ltd. 510(k) NO: K182844(Traditional)
ATTN: Yasuyuki Kawahara PHONE NO : 81 52 7681211
3-100 Akatsuki-cho SE DECISION MADE: 22-JUN-19
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
O & M Halyard, Inc. 510(k) NO: K182851(Abbreviated)
ATTN: Angela L. Bunn PHONE NO : 470 4485158
5405 Windward Parkway SE DECISION MADE: 26-JUN-19
Alpharetta GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReliefBand
ReliefBand Technologies LLC 510(k) NO: K182960(Special)
ATTN: Barbara Whitman PHONE NO : 877 7352263 122
220 Gibraltar Rd Ste 270 SE DECISION MADE: 21-JUN-19
Horsham PA 19044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: emFieldPro
Zimmer MedizinSysteme GmbH 510(k) NO: K182963(Traditional)
ATTN: Ute Hauss PHONE NO : 49 731 9761216
Junkersstrasse 9 SE DECISION MADE: 21-JUN-19
Neu-Ulm DE 89231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearEndoclip
Finemedix Co., Ltd. 510(k) NO: K183021(Traditional)
ATTN: Heon-sik Lee PHONE NO : 82 053 7418388
60, Maeyeo-ro, Dong-gu SE DECISION MADE: 28-JUN-19
Daegu KR 41065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Double Balloon Endoscope EI580BT
FUJIFILM Corporation 510(k) NO: K183032(Traditional)
ATTN: Randy Vader Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 24-JUN-19
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion ONE (TSX-305A/6) V8.9 with AiCE
Canon Medical Systems Corporation 510(k) NO: K183046(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 12-JUN-19
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TxTi IBF System
Innovasis, Inc. 510(k) NO: K183064(Traditional)
ATTN: Marshall McCarty PHONE NO : 801 2612236
614 East 3900 South SE DECISION MADE: 28-JUN-19
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mini Cannulated Headed and Headless Screw Set
Stryker GmbH 510(k) NO: K183104(Traditional)
ATTN: Sanja Jahr PHONE NO : 201 8316797
325 Corporate Drive SE DECISION MADE: 10-JUN-19
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corin BiPolar-i
Corin USA Limited 510(k) NO: K183114(Traditional)
ATTN: Homer Trieu PHONE NO : 813 9774469
12750 Citrus Park Lane SE DECISION MADE: 05-JUN-19
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uWS-CT
Shanghai United Imaging Healthcare510(k) NO: K183170(Traditional)
ATTN: Xin Gao PHONE NO : 86 021670 68885386
NO. 2258 Chengbei Road SE DECISION MADE: 24-JUN-19
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
Ethicon, Inc. 510(k) NO: K183183(Traditional)
ATTN: Stephanie Saati PHONE NO : 908 2183318
Route 22 West P.O. Box 151 SE DECISION MADE: 27-JUN-19
Somerville NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVO
Catheter Precision, Inc. 510(k) NO: K183195(Traditional)
ATTN: Steve Adler PHONE NO : 973 6912000
1705 Route 46 SE DECISION MADE: 14-JUN-19
Ledgewood NJ 07852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trio-CT Triple Lumen Catheter
Medical Components Inc. (dba MedCo510(k) NO: K183219(Traditional)
ATTN: Courtney Nix PHONE NO : 215 2564201
1499 Delp Drive SE DECISION MADE: 14-JUN-19
Harleysville PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoScan TAU Mini C-Arm
Orthoscan, Inc. 510(k) NO: K183220(Traditional)
ATTN: Richard Westrich PHONE NO : 480 5038010
14555 N. 82nd St. SE DECISION MADE: 21-JUN-19
Scottsdale AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Argen Clear Aligner
Argen Corporation 510(k) NO: K183229(Traditional)
ATTN: Paul Cascone PHONE NO : 858 6268612
5855 Oberlin Drive SE DECISION MADE: 07-JUN-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EsoCheck CCD Cell Collection Device
Lucid Diagnostics, Inc. 510(k) NO: K183262(Traditional)
ATTN: Lishan Aklog PHONE NO : 917 6906425
One Grand Central Place, Suite 460SE DECISION MADE: 21-JUN-19
New York NY 10165 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
UNiPACK Medical Corporation 510(k) NO: K183263(Traditional)
ATTN: Joe Pomparelli PHONE NO : 562 7778000
9830 Norwalk Blvd., Suite 100 SE DECISION MADE: 14-JUN-19
Santa Fe Springs CA 90670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invenix Infusion System (IIS)
Ivenix, Inc. 510(k) NO: K183311(Traditional)
ATTN: John J. Sokolowski PHONE NO : 978 7758050
50 High St., Suite 50 SE DECISION MADE: 07-JUN-19
North Andover MA 01845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Poly-Cath Red Polymer Urethral Catheter
Medline Industries, Inc. 510(k) NO: K183335(Traditional)
ATTN: Dinah Rincones PHONE NO : 847 9792687
Three Lakes Drive SE DECISION MADE: 12-JUN-19
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
GX Corporation SDN BHD 510(k) NO: K183354(Traditional)
ATTN: Khon Pu Foo PHONE NO : 60 03 32915788
LOT 6491, Batu 5 3/4, Sementa, JalSE DECISION MADE: 20-JUN-19
Klang MY 42100 510(k) STATEMENT
DEVICE: Treace Medical Concepts (TMC) Snap-Off Screw System
Treace Medical Concepts, Inc. 510(k) NO: K183363(Traditional)
ATTN: Rachel Osbeck PHONE NO : 904 3735940 1304
203 Fort Wade Rd., Suite 150 SE DECISION MADE: 13-JUN-19
Ponte Vedra FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NanoKnife System
Angiodynamics 510(k) NO: K183385(Traditional)
ATTN: Troy Roberts PHONE NO : 508 6587934
26 Forest Street SE DECISION MADE: 18-JUN-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
Hartalega NGC Sdn. Bhd. 510(k) NO: K183389(Traditional)
ATTN: Kuan Leong PHONE NO : 603 62771733
Kawasan Perindustrian Tanjung SE DECISION MADE: 28-JUN-19
Sepang MY 43900 510(k) STATEMENT
DEVICE: Medline Digital Rectal Thermometer Sheath
Medline Industries, Inc. 510(k) NO: K183431(Traditional)
ATTN: Dinah Rincones PHONE NO : 847 9792687
Three Lakes Drive SE DECISION MADE: 14-JUN-19
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmBody System
InMode MD Ltd. 510(k) NO: K183450(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 20-JUN-19
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClariCT.AI
ClariPI Inc. 510(k) NO: K183460(Traditional)
ATTN: Hyun-Sook Park PHONE NO : 82 2 7413014
3F, 70-15, Ihwajang-gil SE DECISION MADE: 13-JUN-19
Seoul KR 03088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XenoSure Dura Biologic Patch
LeMaitre Vascular Inc. 510(k) NO: K183513(Traditional)
ATTN: Xiang Zhang PHONE NO : 781 4251729
63 Second Ave SE DECISION MADE: 13-JUN-19
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unity Total Knee System
Corin USA Limited 510(k) NO: K183533(Traditional)
ATTN: Lucinda Gerber PHONE NO : 772 3212478
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 04-JUN-19
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co., Ltd. 510(k) NO: K183535(Traditional)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9060
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 04-JUN-19
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WatchPAT ONE
Itamar Medical, Ltd. 510(k) NO: K183559(Traditional)
ATTN: Koby Sheffy PHONE NO : 972 4 6177000
9 Halamish St. SE DECISION MADE: 05-JUN-19
Caesarea IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrosurgical Generator
Fullwell LLC 510(k) NO: K183564(Traditional)
ATTN: Xi Chen PHONE NO : 1 305 5353568
3411 NW 48 Street SE DECISION MADE: 13-JUN-19
Miami FL 33142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARITY II Laser System
Lutronic Corporation 510(k) NO: K183566(Traditional)
ATTN: James Childs PHONE NO : 82 31 9083440
Lutronic Center, 219, Sowon-ro SE DECISION MADE: 14-JUN-19
Deogyang-gu, Goyang-si KR 410220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Torpedo Gelatin Foam
Biosphere Medical, S.A. 510(k) NO: K183578(Traditional)
ATTN: Alix Fonlladosa PHONE NO : 33 1 48172529
Parc des Nations – Paris Nord 2, 3SE DECISION MADE: 18-JUN-19
Roissy en France FR 95700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panthera Dental Milled Bars
Panthera Dental Inc. 510(k) NO: K183580(Abbreviated)
ATTN: Martine Fortin PHONE NO : 418 5270388
2035 rue du Haut-Bord SE DECISION MADE: 20-JUN-19
Quebec city CA G1N 4N7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aqua Medical RF Vapor System
Aqua Medical, Inc. 510(k) NO: K183595(Traditional)
ATTN: Lloyd Mencinger PHONE NO : 949 2335172
191 West Second St. SE DECISION MADE: 21-JUN-19
Santa Ana CA 92701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SwimCount Sperm Quality Test
MotilityCount ApS 510(k) NO: K183602(Traditional)
ATTN: Jacob Mollenbach PHONE NO : 45 21 445919
G1. Koge Landevej 55 SE DECISION MADE: 27-JUN-19
Valby DK DK-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROSTEP TBC Implant System
Wright Medical Technology, Inc. 510(k) NO: K183620(Traditional)
ATTN: Michael Mullins PHONE NO : 901 8674142
1023 Cherry Road SE DECISION MADE: 06-JUN-19
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kubtec Mozart (Xpert42)
KUB Technologies, Inc. 510(k) NO: K183624(Traditional)
ATTN: Chester Lowe PHONE NO : 1 203 3648544
111 Research Drive SE DECISION MADE: 20-JUN-19
Stratford CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEART Navigation Instrument System
Spineart SA 510(k) NO: K183630(Traditional)
ATTN: Franck Pennesi PHONE NO :
Chemin du Pre- Fleuri 3 SE DECISION MADE: 10-JUN-19
Plan-les-Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
Baylis Medical Company Inc. 510(k) NO: K183632(Traditional)
ATTN: Meghal Khakhar PHONE NO : 1 905 6024875
2580 Matheson Blvd. E SE DECISION MADE: 07-JUN-19
Mississauga CA L4W 4J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
Baylis Medical Company Inc. 510(k) NO: K183649(Traditional)
ATTN: Meghal Khakhar PHONE NO : 1 905 6024875
2580 Matheson Blvd. E SE DECISION MADE: 07-JUN-19
Mississauga CA L4W 4J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical ENT Video Imaging System
PENTAX of America, Inc. 510(k) NO: K183691(Special)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 12-JUN-19
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avid IF2
Vision Quest Industries Inc./ dba 510(k) NO: K183692(Traditional)
ATTN: Mohamed Ouerghi PHONE NO : 760 4778201
1390 Decision Street, Suite A SE DECISION MADE: 12-JUN-19
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra System Reperfusion Catheter JET 7
Penumbra, Inc. 510(k) NO: K190010(Traditional)
ATTN: Micaela Victoria PHONE NO : 510 9952082
One Penumbra Place SE DECISION MADE: 16-JUN-19
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lateral Plate System
CoreLink, LLC 510(k) NO: K190016(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Park Blvd. SE DECISION MADE: 12-JUN-19
St.Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiverMultiScan (LMSv3)
Perspectum Diagnostics Ltd 510(k) NO: K190017(Traditional)
ATTN: Jaco Jacobs PHONE NO : 44 1865655329
23-38 Hythe Bridge Street SE DECISION MADE: 27-JUN-19
Oxford GB OX1 2ET 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TD Clip
Zephyr Sleep Technologies, Inc. 510(k) NO: K190051(Abbreviated)
ATTN: Sabina Bruehlmann PHONE NO : 587 3320285
102, 701 64 Ave SE SE DECISION MADE: 07-JUN-19
Calgary CA T2H 2C3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radio Frequency Ablation System
Surgnova Healthcare Technologies (510(k) NO: K190052(Traditional)
ATTN: Guofang Ma PHONE NO : 86 10 64116115
No.1 XinXing Yilu Road, Emerging ISE DECISION MADE: 25-JUN-19
Cixi CN 315300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DJO Acetabular System
Encore Medical, L.P. 510(k) NO: K190057(Traditional)
ATTN: Teffany Hutto PHONE NO : 512 8346255
9800 Metric Blvd. SE DECISION MADE: 07-JUN-19
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vanguard XP Knee System
Zimmer Inc. 510(k) NO: K190068(Traditional)
ATTN: Charles Neitzel PHONE NO : 262 7163243
P.O. Box 708 SE DECISION MADE: 04-JUN-19
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Comfort Rubber Gloves Industries S510(k) NO: K190080(Traditional)
ATTN: Chan Yew Men PHONE NO : 605 8472777
Lot 821, Jalan Matang SE DECISION MADE: 27-JUN-19
Matang MY 34750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-Free Clear Vinyl Patient Examination Gloves
Anhui Intco Medical Products Co. L510(k) NO: K190095(Traditional)
ATTN: Jacken Cai PHONE NO : 86 13 853653818
No. 1 Haitang Road, Suixi DistrictSE DECISION MADE: 20-JUN-19
Huaibei CN 235100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R2GATE
MegaGen Implant Co., Ltd. 510(k) NO: K190096(Traditional)
ATTN: HyeJin Jung PHONE NO : 82 70 43521120
41940, 10F, 12 Gong Pyeong Ro, JunSE DECISION MADE: 26-JUN-19
Daegu KR 41940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann CARES Screw-Retained Bridges and Bars
Institut Straumann AG 510(k) NO: K190097(Traditional)
ATTN: Gordon Dodds PHONE NO : 49 89 309075291
Peter Merian-Weg 12 SE DECISION MADE: 26-JUN-19
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraFlex IAB
Arrow International, Inc. 510(k) NO: K190101(Traditional)
ATTN: Niyati Boghani PHONE NO : 978 2505100
16 Elizabeth Drive SE DECISION MADE: 28-JUN-19
Chelmsford MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle
Centerline Biomedical, Inc. 510(k) NO: K190106(Traditional)
ATTN: Vikash Goel PHONE NO : 1 440 5331950
10000 Cedar Ave SE DECISION MADE: 24-JUN-19
Cleveland OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MHD TENS
MingHuangDa Electronic Co., Ltd 510(k) NO: K190115(Traditional)
ATTN: Zhang Guixiang PHONE NO : 86 755 27935858
Floor6, Building A, Taixinglong InSE DECISION MADE: 19-JUN-19
Baoan District, Shenzhen CN 51810510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fiberoptix IAB
Arrow International, Inc. 510(k) NO: K190117(Traditional)
ATTN: Niyati Boghani PHONE NO : 978 2505100
16 Elizabeth Drive SE DECISION MADE: 13-JUN-19
Chelmsford MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDS SHBG
Immunodiagnostic Systems Ltd. 510(k) NO: K190121(Traditional)
ATTN: Mick Henderson PHONE NO : 44 191 5190660
10 Didcot Way Boldon Business ParkSE DECISION MADE: 17-JUN-19
Boldon GB NE35 9PD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renovis A200 PS Knee System as part of the Renovis A200 Knee System
Renovis Surgical Technologies 510(k) NO: K190122(Traditional)
ATTN: Anthony Debenedictis PHONE NO : 909 5572360
1901 W. Lugonia Ave, Suite 340 SE DECISION MADE: 20-JUN-19
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The ClearSight finger cuffs
Edwards Lifesciences, LLC 510(k) NO: K190130(Traditional)
ATTN: Christine J. Chun PHONE NO : 949 2502773
One Edwards Way SE DECISION MADE: 21-JUN-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
Health & Life Co., Ltd. 510(k) NO: K190133(Special)
ATTN: JS Hsu PHONE NO : 886 2 82271300 1201
9F. No.186, Jian Yi Road SE DECISION MADE: 13-JUN-19
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vit Kit- Freeze NX and Vit Kit- Warm NX
FUJIFILM Irvine Scientific, Inc. 510(k) NO: K190152(Traditional)
ATTN: Jayme Yamaguchi-Owens PHONE NO : 949 2617800 254
2511 Daimler Street SE DECISION MADE: 21-JUN-19
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
Stryker 510(k) NO: K190172(Traditional)
ATTN: David Colao PHONE NO : 269 3894285
4100 E. Milham Ave SE DECISION MADE: 14-JUN-19
Kalamazoo MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,
Ranfac Corporation 510(k) NO: K190177(Special)
ATTN: Eric Kreuz PHONE NO : 508 5884400 137
30 Doherty Ave SE DECISION MADE: 12-JUN-19
Avon MA 02322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phasix ST Mesh with Open Positioning System
C.R. Bard, Inc. 510(k) NO: K190185(Traditional)
ATTN: Shirin Mate PHONE NO : 401 8258569
100 Crossings Boulevard SE DECISION MADE: 12-JUN-19
Warwick RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpaceFlex Knee
G21 S.R.L 510(k) NO: K190216(Traditional)
ATTN: Filippo Foroni PHONE NO : 39 05 3530312
Via Sandro Petrini, 8 SE DECISION MADE: 09-JUN-19
San Possidonio IT 41039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vista FS, Vista FS Liquid
Inter-Med / Vista Dental Products 510(k) NO: K190220(Traditional)
ATTN: Alex Johnson PHONE NO : 262 6315306
2200 South St. Ste. A SE DECISION MADE: 10-JUN-19
Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transcranial Doppler Ultrasound System
Shenzhen Delica Medical Equipment 510(k) NO: K190228(Traditional)
ATTN: Yolanda Lan PHONE NO : 86 755 2613482115
F, Block 10, The Second IndustrialSE DECISION MADE: 13-JUN-19
Shenzhen CN 51855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PDS Barbed Suture, PDO MAXX Threads
PDO MAX, Inc. 510(k) NO: K190245(Abbreviated)
ATTN: Giovanna McCarthy PHONE NO : 1 315 7089913
4971 Bear Road SE DECISION MADE: 04-JUN-19
Liverpool NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RecoveryRx
BioElectronics Corporation 510(k) NO: K190251(Traditional)
ATTN: Sree N Koneru PHONE NO : 301 5002061
4539 Metropolitan Ct SE DECISION MADE: 28-JUN-19
Federick MD 21704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elos Accurate® Customized Abutment
Elos Medtech Pinol A/S 510(k) NO: K190299(Traditional)
ATTN: Tina Friis Poulsen PHONE NO : 00 454 8216469
Engvej 33 SE DECISION MADE: 26-JUN-19
Goerloese DK DK-3330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soniquence Bipolar Electrodes
Soniquence, LLC 510(k) NO: K190336(Traditional)
ATTN: Suzanne Lucas PHONE NO : 516 6548017
2473 Grand Avenue SE DECISION MADE: 20-JUN-19
Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReWalk Restore
ReWalk Robotics Ltd. 510(k) NO: K190337(Traditional)
ATTN: Ofir Koren PHONE NO : 972 54 5225792
3 Hetnufa st., POB Box- 161 SE DECISION MADE: 03-JUN-19
Yokneam IL 2069203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iC-GN iC-Cassette for use on the iC-System
iCubate, Inc. 510(k) NO: K190341(Traditional)
ATTN: Carter Wells PHONE NO : 256 8813692
601 Genome Way SE DECISION MADE: 28-JUN-19
Huntsville AL 35806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LineSider™ Spinal System
Integrity Implants, Inc 510(k) NO: K190360(Traditional)
ATTN: Lauren Kamer PHONE NO : 561 5293861
850 Parkway Street SE DECISION MADE: 21-JUN-19
Jupiter FL 33477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RayStation
RaySearch Laboratories AB (publ) 510(k) NO: K190387(Traditional)
ATTN: David Hedfors PHONE NO : 46 8510 53000
Sveavagen 44 SE DECISION MADE: 19-JUN-19
Stockholm SE 111 34 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIVAL View Plating Systems and Reduce Fracture Plating Systems
Orthofix Srl 510(k) NO: K190388(Traditional)
ATTN: Gianluca Ricadona PHONE NO : 34 045 6719000
Via delle Nazioni, 9 SE DECISION MADE: 07-JUN-19
Bussolengo IT 37012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
Moss Tubes, Inc. 510(k) NO: K190414(Special)
ATTN: Michael Moss PHONE NO : 518 6743109
1929 Route 9 SE DECISION MADE: 14-JUN-19
Castleton on Hudson NY 12033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viveve System 2.0
Viveve Medical 510(k) NO: K190422(Traditional)
ATTN: Suzon Lommel PHONE NO : 408 6454979
345 Inverness Drive South, BuildinSE DECISION MADE: 12-JUN-19
Englewood CO 80109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HealthICH
Zebra Medical Vision Ltd. 510(k) NO: K190424(Traditional)
ATTN: Flair Bar PHONE NO : 972 9 8827795
Shefayim Commercial Center, PO BoxSE DECISION MADE: 13-JUN-19
Shefayim IL 6099000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MMSphere
Galactic Beauty, LLC 510(k) NO: K190443(Traditional)
ATTN: Ellen Marmur PHONE NO : 877 4425228
12 E 87 ST STE 1A SE DECISION MADE: 24-JUN-19
New York NY 10128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
Philips Medical Systems Nederland 510(k) NO: K190461(Abbreviated)
ATTN: Jan van de Kerkhof PHONE NO : 31 61 3300542
Veenpluis 4-6 SE DECISION MADE: 04-JUN-19
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4
CenterPoint Systems 510(k) NO: K190475(Traditional)
ATTN: Marybeth Gamber PHONE NO : 774 2495250
3338 Parkway Blvd SE DECISION MADE: 28-JUN-19
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CeraSeal
Meta Biomed Co., Ltd. 510(k) NO: K190503(Traditional)
ATTN: Suk Song Oh PHONE NO : 82 43 2308959
270, Osong Saengmyeong 1-ro Osong-SE DECISION MADE: 07-JUN-19
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Low Dose Lung Screening Option
Canon Medical Systems Corporation 510(k) NO: K190505(Traditional)
ATTN: Paul Biggins PHONE NO : 81 287 266478
1385 Shimoishigami SE DECISION MADE: 05-JUN-19
Otawara JP 3248550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroLink All-Suture Button Fixation System (Radiolucent)
CONMED Corporation 510(k) NO: K190516(Traditional)
ATTN: Diana L. Nader-Martone PHONE NO : 727 3995425
525 French Road SE DECISION MADE: 28-JUN-19
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aequalis Ascend Flex Shoulder System
Tornier SAS 510(k) NO: K190521(Special)
ATTN: Lamia Askri PHONE NO : 33 47 6613500
161 Rue Lavoisier SE DECISION MADE: 12-JUN-19
Monbonnot Saint Martin FR 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
icotec ag 510(k) NO: K190545(Traditional)
ATTN: Marina Hess PHONE NO : 41 71 7570024
Industriestrasse 12 SE DECISION MADE: 20-JUN-19
9450 Altstaetten CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
Bionime Corporation 510(k) NO: K190564(Traditional)
ATTN: Shane Chou PHONE NO : 886 4 23692388
No. 100, Sec. 2, Daqing St., SouthSE DECISION MADE: 02-JUN-19
Taichung TW 40242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ComPAS2 (Computerized Pulmonary Analysis System)
Morgan Scientific, Inc. 510(k) NO: K190568(Special)
ATTN: Deborah Cornish PHONE NO : 978 5214440
151 Essex Street STE 8 SE DECISION MADE: 06-JUN-19
Haverhill MA 01832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erchonia FX-635
Erchonia Corporation 510(k) NO: K190572(Traditional)
ATTN: Steven Shanks PHONE NO : 321 4731251
650 Atlantis Rd. SE DECISION MADE: 01-JUN-19
Melbourne FL 32904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOWA DR-1a
Kowa Company, Ltd. 510(k) NO: K190573(Traditional)
ATTN: Nariaki Morita PHONE NO : 81 42 4407612
3-1, Chofugaoka 3-Chome SE DECISION MADE: 04-JUN-19
Chofu JP 1820021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WalterLorenz Surgical Assist Arm Scope Holder
Biomet Microfixation 510(k) NO: K190576(Traditional)
ATTN: Lauren Jasper PHONE NO : 904 7419259
1520 Tradeport Drive SE DECISION MADE: 05-JUN-19
Jacksonville FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
Siemens Medical Solutions USA Inc.510(k) NO: K190578(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 4486477
40 Liberty Blvd. SE DECISION MADE: 27-JUN-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TD-4183 Blood Glucose Monitoring System
TaiDoc Technology Corporation 510(k) NO: K190579(Traditional)
ATTN: Sophia Wu PHONE NO : 886 2 66258188
6F, No.127, Wugong 2nd Rd., Wugu DSE DECISION MADE: 04-JUN-19
New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroLink All-Suture Button Fixation System (Radiopaque)
CONMED Corporation 510(k) NO: K190582(Traditional)
ATTN: Diana L. Nader-Martone PHONE NO : 727 3995425
525 French Road SE DECISION MADE: 28-JUN-19
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DynaFlex
DynaFlex 510(k) NO: K190583(Traditional)
ATTN: Matthew Malabey PHONE NO : 314 4264020
10403 International Plaza Dr. SE DECISION MADE: 27-JUN-19
St. Ann MO 63074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biocode Gastrointestinal Pathogen Panel (GPP)
Applied Biocode, Inc. 510(k) NO: K190585(Traditional)
ATTN: Robert Di Tullio PHONE NO : 562 8010050
10020 Pioneer Blvd. Suite 102 SE DECISION MADE: 05-JUN-19
Santa Fe Springs CA 900670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signature ONE System
Orthosoft Inc. (d/b/a Zimmer CAS) 510(k) NO: K190595(Traditional)
ATTN: Paul Hardy PHONE NO : 574 3726799
75 Queen Street Suite 3300 SE DECISION MADE: 05-JUN-19
Montreal CA h3c 2n6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRILLIANT EverGlow Flow
Coltene/Whaledent AG 510(k) NO: K190597(Traditional)
ATTN: Wolfgang Dorner PHONE NO : 0041 75 7575422
Feldwiesenstrasse 20 SE DECISION MADE: 21-JUN-19
Altstatten CH 9450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
bioMerieux, Inc. 510(k) NO: K190616(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Road SE DECISION MADE: 06-JUN-19
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGEL PEEK Anterior Cervical Interbody Fusion System
MiRus, LLC 510(k) NO: K190618(Traditional)
ATTN: Jordan Bauman PHONE NO : 678 3246272
2150 Newmarket Parkway SE DECISION MADE: 06-JUN-19
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann CI RD Ceramic Healing Caps
Institut Straumann AG 510(k) NO: K190654(Traditional)
ATTN: Pierre-Yves Calinon PHONE NO : 41 61 9651604
Peter Merian-Weg 12 SE DECISION MADE: 28-JUN-19
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI Compatibility for Existing Straumann Dental Implant Systems
Straumann USA LLC 510(k) NO: K190662(Traditional)
ATTN: Loretta Kushner-Mooney PHONE NO : 41 61 6951260
60 Minuteman Road SE DECISION MADE: 17-JUN-19
Andover MA 01810 510(k) STATEMENT
DEVICE: Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
Pajunk GmbH Medizintechnologie 510(k) NO: K190663(Traditional)
ATTN: Christian G. H. Quass PHONE NO : 49 770 49291586
Karl-Hall-Str. 1 SE DECISION MADE: 17-JUN-19
Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonopet iQ Sterilization Tray
Paragon Medical 510(k) NO: K190667(Traditional)
ATTN: Rebecca Walker PHONE NO : 574 5942140
8 Matchett Dr. SE DECISION MADE: 13-JUN-19
Pierceton IN 46562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LxHA PEEK Lateral IBF System
Innovasis, Inc. 510(k) NO: K190684(Traditional)
ATTN: Marshall McCarty PHONE NO : 801 2612236
614 East 3900 South SE DECISION MADE: 17-JUN-19
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Surgeon iD Mandible Recon Plate
Stryker 510(k) NO: K190696(Special)
ATTN: Zainab Amini PHONE NO : 269 3898349
750 Trade Centre Way - Suite 200 SE DECISION MADE: 28-JUN-19
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRODES PAD
Shenzhen Bestpad Technology Develo510(k) NO: K190700(Traditional)
ATTN: Junwei Xu PHONE NO : 86 755 82593905
A16A17 Dong Jing Run Factory A301,SE DECISION MADE: 14-JUN-19
Shenzhen CN 518105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venus Bliss
Venus Concept USA Inc. 510(k) NO: K190743(Traditional)
ATTN: Yoni Iger PHONE NO : 972 549 599215
1880 N Commerce Pkwy, Suite 2 SE DECISION MADE: 25-JUN-19
Weston FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Plates and Screws Portfolio
DePuy Synthes 510(k) NO: K190750(Traditional)
ATTN: Quinn McCarthy PHONE NO : 610 7196730
1301 Goshen Parkway SE DECISION MADE: 21-JUN-19
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthoss(R)
Geistlich Pharma AG 510(k) NO: K190754(Traditional)
ATTN: Marco Steiner PHONE NO : 41 41 4926764
Bahnhofstrasse 40 SE DECISION MADE: 23-JUN-19
Wolhusen CH CH-6110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The JASPER Spinal Fixation System II
GBS Commonwealth Co., Ltd. 510(k) NO: K190762(Traditional)
ATTN: Jimmy Kim PHONE NO : 82 2 69254469
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 19-JUN-19
Geumcheon-gu KR 08507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trevo XP ProVue Retriever
Stryker 510(k) NO: K190779(Traditional)
ATTN: Rhoda M. Santos PHONE NO : 510 4132269
47900 Bayside Parkway SE DECISION MADE: 25-JUN-19
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexGard Cut-Resistant Glove Liners
LDI Corporation 510(k) NO: K190782(Abbreviated)
ATTN: Lou LaMarca PHONE NO : 603 4360077
3560 Lafayette Road, Building 2 SE DECISION MADE: 27-JUN-19
Portsmouth NH 03801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUHLMANN fCAL turbo
BUHLMANN Laboratories AG 510(k) NO: K190784(Traditional)
ATTN: Laura Zurbrugg PHONE NO : 41 61 4871250
Baselstrasse 55 SE DECISION MADE: 25-JUN-19
Schonenbuch CH 4124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Innovative Health, LLC. 510(k) NO: K190785(Traditional)
ATTN: Amanda Babcock PHONE NO : 480 5255911
1435 North Hayden Road, Suite 100 SE DECISION MADE: 25-JUN-19
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HydroCision TenJet Device
HydroCision, Inc. 510(k) NO: K190804(Traditional)
ATTN: Mark J. Lewis PHONE NO : 978 2891333
267 Boston Rd, Suite 28 SE DECISION MADE: 05-JUN-19
North Billerica MA 01862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuFill Bone Substitute Material
Zimmer Knee Creations 510(k) NO: K190814(Traditional)
ATTN: David l. Nichols PHONE NO :
841 Springdale Drive SE DECISION MADE: 10-JUN-19
Exton PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
UVision360 Inc. 510(k) NO: K190827(Special)
ATTN: Allison London Brown PHONE NO : 888 8559360
158 Wind Chime Ct. Ste. 201 SE DECISION MADE: 06-JUN-19
Raleigh NC 27615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise Mimics Enlight
Materialise N.V. 510(k) NO: K190874(Traditional)
ATTN: Mieke Janssen PHONE NO : 32 16 396611
Technologielaan 15 SE DECISION MADE: 05-JUN-19
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Republic Spine Restore Cervical Interbody Fusion System
Republic Spine, L.L.C. 510(k) NO: K190889(Traditional)
ATTN: James Doulgeris PHONE NO : 561 3628094
2424 N. Federal Hwy SE DECISION MADE: 19-JUN-19
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaScrew PEEK Interference Screw
Medacta International SA 510(k) NO: K190892(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 04-JUN-19
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QLAB Advanced Quantification Software 13
Philips Healthcare 510(k) NO: K190913(Third Party - Special)
ATTN: Arti Arvind PHONE NO : 978 6597364
22100 Bothell Everett Highway SE DECISION MADE: 18-JUN-19
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
VitalConnect, Inc. 510(k) NO: K190916(Traditional)
ATTN: Cynthia Merrell PHONE NO : 1 408 9634600
224 Airport Parkway, Suite 300 SE DECISION MADE: 07-JUN-19
San Jose CA 95110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oscillometric Blood Pressure Monitor
Rudolf Riester GmbH 510(k) NO: K190927(Traditional)
ATTN: Vivi Ding PHONE NO : 49 7477 927043
P.O. Box 35 Bruckstrasse 31 SE DECISION MADE: 24-JUN-19
Jungingen DE D-72417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-Switched Nd: YAG Laser System
Shanghai Apolo Medical Technology 510(k) NO: K190936(Traditional)
ATTN: Felix Li PHONE NO : 86 1384 9190618
4F, Building A. No.388, Yindu RoadSE DECISION MADE: 17-JUN-19
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Photodynamic Therapy System
Shanghai Apolo Medical Technology 510(k) NO: K190938(Traditional)
ATTN: Felix Li PHONE NO : 86 138 49190618
4F, Building A. No.388, Yindu RoadSE DECISION MADE: 26-JUN-19
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProLift® Expandable System
Life Spine Inc. 510(k) NO: K191005(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 13-JUN-19
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SyMRI
SyntheticMR AB 510(k) NO: K191036(Traditional)
ATTN: Maria Almesaker PHONE NO : 46 070 4151007
Storgatan 11 SE DECISION MADE: 13-JUN-19
Linkoping SE 582 23 510(k) STATEMENT
DEVICE: On Call Express Voice Blood Glucose Monitoring System
ACON Laboratories, Inc. 510(k) NO: K191038(Special)
ATTN: Qiyi Xie PHONE NO : 858 8758011
10125 Mesa Rim Road SE DECISION MADE: 12-JUN-19
San Diego CA 92121 510(k) STATEMENT
DEVICE: da Vinci Handheld Camera
Intuitive Surgical, Inc. 510(k) NO: K191043(Traditional)
ATTN: Manjunath Bisalehalli PHONE NO : 408 5237089
1266 Kifer Road SE DECISION MADE: 06-JUN-19
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker MIS and Footed Attachments
Stryker Corporation 510(k) NO: K191049(Traditional)
ATTN: Paminder Khurmi PHONE NO : 269 3897700 2264
4100 E Milham Ave SE DECISION MADE: 18-JUN-19
Kalamazoo MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K191055(Traditional)
ATTN: Scully Kim PHONE NO : 82 2 21941312
3366, Hanseo-ro, Nam-myeon, SE DECISION MADE: 12-JUN-19
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Argon Handset
New Deantronics Taiwan Ltd 510(k) NO: K191064(Traditional)
ATTN: Jane Liu PHONE NO : 886 2 22681726
12F., No.51, Sec.4, Chong Yang Rd.SE DECISION MADE: 12-JUN-19
New Taipei City TW 23675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7410 Ultrasound System (MyLabSigma)
Esaote S.p.A. 510(k) NO: K191072(Special)
ATTN: Piet De Jong PHONE NO : 39 055 4229319
Via Enrico Melen 77 SE DECISION MADE: 10-JUN-19
Genova IT 16152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Edwards Pressure Cable
Edwards LifeSciences, LLC 510(k) NO: K191089(Traditional)
ATTN: Anne Lo PHONE NO : 949 2503386
One Edwards Way SE DECISION MADE: 13-JUN-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd 510(k) NO: K191115(Special)
ATTN: Ji Yea Lee PHONE NO : 82 22194 1594
3366 Hanseo-ro,Nam-myeon SE DECISION MADE: 12-JUN-19
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Titan 3T, MRT-3010, V2.5
Canon Medical Systems Corporation 510(k) NO: K191128(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 26-JUN-19
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JKH Stimulator Plus
JKH USA, LLC 510(k) NO: K191151(Special)
ATTN: Bill Quanqin Dai PHONE NO : 909 9299896
1142 S. Diamond Bar Blvd, #861 SE DECISION MADE: 21-JUN-19
Diamond Bar CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DigniCap Delta
Dignitana Inc. 510(k) NO: K191166(Traditional)
ATTN: William Cronin PHONE NO : 469 9175555
10925 Estate Lane, Suite W-185 SE DECISION MADE: 26-JUN-19
Dallas TX 75238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cepheid Xpert SA Nasal Complete Control Panel
Microbiologics, Inc. 510(k) NO: K191168(Traditional)
ATTN: Tina Sobania PHONE NO : 320 2297050
200 Cooper Avenue North SE DECISION MADE: 25-JUN-19
St. Cloud MN 56303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cepheid Xpert MRSA NxG Control Panel
Microbiologics, Inc. 510(k) NO: K191172(Traditional)
ATTN: Tina Sobania PHONE NO : 320 2297050
200 Cooper Avenue North SE DECISION MADE: 20-JUN-19
St. Cloud MN 56303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
ACIST Medical Systems, Inc. 510(k) NO: K191175(Traditional)
ATTN: Angela Johnson PHONE NO : 952 9939300
7905 Fuller Rd. SE DECISION MADE: 27-JUN-19
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solanas® Posterior OCT Fixation System
Alphatec Spine 510(k) NO: K191185(Traditional)
ATTN: Ruby Zheng PHONE NO : 760 4946884
5818 El Camino Real SE DECISION MADE: 03-JUN-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARUS
Carl Zeiss Meditec, Inc 510(k) NO: K191194(Traditional)
ATTN: Saurabh Jamkhindikar PHONE NO : 925 5574696
5160 Hacienda Drive SE DECISION MADE: 25-JUN-19
Dublin CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
Taiwan Aulisa Medical Devices Tech510(k) NO: K191207(Special)
ATTN: Paul Liu PHONE NO : 886 2 26557297 221
Rm. 1052, Bldg. H, 10F., No.3-2, YSE DECISION MADE: 25-JUN-19
Taipei City TW 115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aneroid Type Blood Pressure Kit
Dongguan Mars Medical Products Co.510(k) NO: K191209(Traditional)
ATTN: Lily Liao PHONE NO : 86 769 85834233
381, Manfeng West Road, Manfeng GrSE DECISION MADE: 18-JUN-19
Dani Village, Shatian Town, Donggu510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pure Vu System
Motus GI Medical Technologies Ltd.510(k) NO: K191220(Special)
ATTN: Ravit Peled PHONE NO : 972 4 6214447
22 Keren Ha'yesod St. SE DECISION MADE: 06-JUN-19
Tirat Carmel IL 3902638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIO
Blue Belt Technologies, Inc. 510(k) NO: K191223(Special)
ATTN: Amy Winegarden PHONE NO : 763 4524950
2905 Northwest Blvd., Ste. 40 SE DECISION MADE: 28-JUN-19
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SwiveLock Suture Anchor
Arthrex Inc. 510(k) NO: K191226(Special)
ATTN: David L. Rogers PHONE NO : 1 239 5984302 71924
1370 Creekside Boulevard SE DECISION MADE: 11-JUN-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Andorate Auxiliary Water Connector, Andorate Valves Set
Smartdata Suzhou Co., Ltd 510(k) NO: K191231(Third Party - Traditional)
ATTN: Cindy Ye PHONE NO : 86 512 65983722
4F, Block 7, 198#, Jinshan Rd SE DECISION MADE: 07-JUN-19
Suzhou CN 215011 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Idys ALIF TiVac
Clariance SAS 510(k) NO: K191263(Special)
ATTN: Fadwa Bahr PHONE NO : 33 3 21161215
18 rue Robespierre SE DECISION MADE: 06-JUN-19
Beaurains FR 62217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Force Fiber Suture
Teleflex Medical Incorporated 510(k) NO: K191268(Special)
ATTN: Andrea Curria PHONE NO : 508 9646030
375 Forbes Boulevard SE DECISION MADE: 11-JUN-19
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma Gmbh 510(k) NO: K191271(Special)
ATTN: Heike Gustke PHONE NO : 49 4348 702637
Prof-Kuentscher-Str. 1-5 SE DECISION MADE: 11-JUN-19
Schoenkirchen DE 24232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spine & Trauma Navigation
Brainlab AG 510(k) NO: K191285(Special)
ATTN: Julia Mehltretter PHONE NO : 49 89 9915680
Olof-Palme-Str. 9 SE DECISION MADE: 11-JUN-19
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wallace Dual Lumen Oocyte Recovery System
CooperSurgical, Inc. 510(k) NO: K191291(Special)
ATTN: Christine Kupchick PHONE NO : 203 6015200 3370
95 Corporate Drive SE DECISION MADE: 12-JUN-19
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silhouette Featherlift / Silhouette Lift
Silhouette Lift Inc. 510(k) NO: K191299(Special)
ATTN: Anthony DiBernardo PHONE NO : 949 7272074
1 Technology Drive F211 SE DECISION MADE: 14-JUN-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Palm Bladder Scanner - PBSV5.1
Mianyang Meike Electronic Equipmen510(k) NO: K191307(Special)
ATTN: Wenjun Zhao PHONE NO : 086 13 308119236
No. 63, Yinping Road, Longmen TownSE DECISION MADE: 05-JUN-19
Mianyang CN 621000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insight Essentials DRF Digital Imaging System
Imaging Engineering, LLC 510(k) NO: K191310(Traditional)
ATTN: George Jachode PHONE NO : 239 2231371
1318 NW 7th Ave SE DECISION MADE: 10-JUN-19
Cape Coral FL 33993 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS XT Chemistry Products ALB-TP Slides
Ortho-Clinical Diagnostics, Inc. 510(k) NO: K191316(Traditional)
ATTN: Darlene Phillips PHONE NO : 585 4534253
100 Indigo Creek Drive SE DECISION MADE: 07-JUN-19
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS FLEX REVIVE Shoulder System
Tornier, Inc. 510(k) NO: K191318(Special)
ATTN: Katie Molland PHONE NO : 952 6837446
10801 Nesbitt Avenue South SE DECISION MADE: 14-JUN-19
Bloomington MN 55340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Life Sensor Cardiac Monitor
BraveHeart Wireless, Inc. 510(k) NO: K191331(Third Party - Traditional)
ATTN: Balaji Sudabattula PHONE NO : 385 9880625
11 Perimeter Road SE DECISION MADE: 12-JUN-19
Nashua NH 03063 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
Corinth MedTech, Inc. 510(k) NO: K191335(Special)
ATTN: Sandeep Saboo PHONE NO : 408 9962517
1601 S. De Anza Blvd, Suite 200 SE DECISION MADE: 06-JUN-19
Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORTRAK* 2 Equilateral Enteral Access System
Avanos Medical, Inc. 510(k) NO: K191340(Third Party - Special)
ATTN: Monica King PHONE NO : 678 4774165
5405 Windward Parkway SE DECISION MADE: 04-JUN-19
Alpharetta GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
Corinth MedTech, Inc. 510(k) NO: K191341(Special)
ATTN: Sandeep Saboo PHONE NO : 408 9962517
1601 S. De Anza Blvd, Suite 200 SE DECISION MADE: 13-JUN-19
Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowTriever Retrieval/Aspiration System
Inari Medical 510(k) NO: K191368(Special)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 17-JUN-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
Envizion Medical Ltd. 510(k) NO: K191387(Special)
ATTN: Doron Besser PHONE NO : 972 72 2288240
7 Haarad St. SE DECISION MADE: 14-JUN-19
Tel Aviv IL 6971060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FloPatch (FP110)
Flosonics Medical (r/a 1929803 Ont510(k) NO: K191388(Third Party - Traditional)
ATTN: Joe Eibl PHONE NO : 705 6266419
204-73 Elm Street SE DECISION MADE: 21-JUN-19
Sudbury CA P3C 1R7 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Voyager Trajectory Array Guide (V-TAG)
MRI Interventions, Inc. 510(k) NO: K191400(Special)
ATTN: Pete Piferi PHONE NO : 949 9006833
5 Musick SE DECISION MADE: 21-JUN-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multix Fusion Max
Siemens Medical Solutions USA, Inc510(k) NO: K191418(Special)
ATTN: Martin Rajchel PHONE NO : 610 4486545
40 Liberty Boulevard, Mailcode 65-SE DECISION MADE: 19-JUN-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
Erbe USA, Inc. 510(k) NO: K191438(Special)
ATTN: John Tartal PHONE NO : 770 9554400
2225 Northwest Parkway SE DECISION MADE: 27-JUN-19
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Campylobacter Chek
Techlab, Inc. 510(k) NO: K191442(Special)
ATTN: Donna Link PHONE NO : 540 9531664
2001 Kraft Drive SE DECISION MADE: 20-JUN-19
Blacksburg VA 24085 510(k) STATEMENT
DEVICE: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
Dexcom, Inc. 510(k) NO: K191450(Special)
ATTN: Emily Chung PHONE NO : 858 5294737
6310 Sequence Dr. SE DECISION MADE: 28-JUN-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Campylobacter Quik Chek
Techlab, Inc 510(k) NO: K191456(Special)
ATTN: Donna Link PHONE NO : 540 9531664
2001 Kraft Drive SE DECISION MADE: 20-JUN-19
Blacksburg VA 24085 510(k) STATEMENT
DEVICE: Human IgM Kit for use on SPAPlus
The Binding Site Group Ltd. 510(k) NO: K191465(Special)
ATTN: Natasha Verhaak PHONE NO : 44 0121 4569500
8 Calthorpe Road SE DECISION MADE: 27-JUN-19
Edgbaston GB B15 1qt 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALIX ADVANCE Anchor with DYNA+TAPE Sutures
Medos International SARL 510(k) NO: K191483(Special)
ATTN: Ashley Goncalo PHONE NO : 508 9773907
Chemin-Blanc 38, Case Postale SE DECISION MADE: 28-JUN-19
Le Locle CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deflectable Brush Biopsy Set
Cook Incorporated 510(k) NO: K191485(Traditional)
ATTN: Irasema Rivera PHONE NO : 812 3353575 105166
750 Daniels Way SE DECISION MADE: 26-JUN-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 220
TOTAL WITH SUMMARIES 210
TOTAL WITH STATEMENTS 10
