510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2018
DEVICE: PENTAX MEDICAL ED-3490TK, Video Duodenoscope
PENTAX MEDICAL 510(k) NO: K161222(Traditional)
ATTN: KANCHANA IYER PHONE NO : 800 4315880 5170
3 PARAGON DRIVE SE DECISION MADE: 07-FEB-18
MONTVALE NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIUM Implant Systems SHELTA Implant Systems
SWEDEN & MARTINA S.p.A. 510(k) NO: K161989(Traditional)
ATTN: Alessia Pezzato PHONE NO : 39 049 9124300
via veneto, 10 SE DECISION MADE: 01-FEB-18
Due Carrare IT 35020 510(k) STATEMENT
DEVICE: SENYINT Remote Consultation System
Dalian Senyint Digital Medical Sys510(k) NO: K162727(Traditional)
ATTN: Yinghui Miao PHONE NO : 086 411 84789898
Room 403-404, Building 3, East Rd.SE DECISION MADE: 08-FEB-18
Dalian CN 116023 510(k) STATEMENT
DEVICE: Captura Disposable Bronchoscope Biopsy Forceps
Wilson-Cook Medical Inc. 510(k) NO: K163377(Traditional)
ATTN: Ashley Howard PHONE NO : 336 7440157 6174
4900 Bethania Station Road SE DECISION MADE: 21-FEB-18
Winstom-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMD's Lumbar Puncture Needle
INTERNATIONAL MEDICAL DEVELOPMENT,510(k) NO: K170112(Traditional)
ATTN: WALTER ZOHMANN PHONE NO : 800 8248223
560 HIGHWAY 39 (PO BOX 510) SE DECISION MADE: 02-FEB-18
HUNTSVILLE UT 84317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAV Medical Dental Implants System
Tav Medical Ltd. 510(k) NO: K170131(Traditional)
ATTN: Revital Shabtai PHONE NO : 972 4 9808615
Dora Industrial Park, P.O. Box 88 SE DECISION MADE: 10-FEB-18
Shlomi IL 2283202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSEAL MTA
MARUCHI 510(k) NO: K170175(Traditional)
ATTN: Jang Sung Wook PHONE NO : 82 33 7340330
2-208, 42-10, Taejanggongdan-gil SE DECISION MADE: 26-FEB-18
Wonju-si KR 26311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DM-Density
Densitas, Inc. 510(k) NO: K170540(Traditional)
ATTN: Mo Abdolell PHONE NO : 1 902 4025505
1344 Summer Street, Suite 311.2 SE DECISION MADE: 23-FEB-18
Halifax CA B3H 0A8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE Hemoglobin A1c (HbA1c) Reagent
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K170623(Traditional)
ATTN: Barbara Phillips PHONE NO : 973 8520112
4 Henderson Drive SE DECISION MADE: 27-FEB-18
West Caldwell NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
Aesculap, Inc. 510(k) NO: K170683(Traditional)
ATTN: Jessica Stigliano PHONE NO : 610 9849063
3773 Corporate Parkway SE DECISION MADE: 20-FEB-18
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SuRgical Planner (SRP)
Surgical Theater, LLC 510(k) NO: K170793(Traditional)
ATTN: Kevin Murrock PHONE NO : 330 4726520
781 Beta Drive SE DECISION MADE: 12-FEB-18
Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
Honsun(Nantong)Co.,Ltd 510(k) NO: K170866(Special)
ATTN: Selina Qian PHONE NO : 86 051 380580116
No.8,Tongxing Road, Economic&TechnSE DECISION MADE: 21-FEB-18
Nantong CN 226009 510(k) STATEMENT
DEVICE: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
Koon Seng Sdn. Bhd. 510(k) NO: K171171(Traditional)
ATTN: Koon Seng Sdn. Bhd. PHONE NO :
PTD 16058 Kawasan Perindustrian TaSE DECISION MADE: 22-FEB-18
Jalan Muar MY 84900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BR Type Implant System
Biotem Co.,Ltd. 510(k) NO: K171179(Traditional)
ATTN: Hong Koo Yeo PHONE NO : 82 70 82204934
57, Sasang-ro, 401 beon-gil, SasanSE DECISION MADE: 09-FEB-18
BUSAN KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trans-anal Introducer
Visionsense Ltd. 510(k) NO: K171208(Traditional)
ATTN: Alex Chanin PHONE NO : 972 392 44339
20 Hamagshimim St. SE DECISION MADE: 05-FEB-18
Petach Tikva, Hamerkaz IL 49348 510(k) STATEMENT
DEVICE: Sporview VH202 BI
SPSmedical Supply Corp. A Division510(k) NO: K171287(Traditional)
ATTN: Brent Geiger PHONE NO : 800 7221529
6789 West Henrietta Rd SE DECISION MADE: 01-FEB-18
Rush NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BETTERCARE PLATFORM - ADVANCED WEB CLIENT
Bettercare S.L. 510(k) NO: K171361(Traditional)
ATTN: Bernat Sales PHONE NO : 0034 65 6939648
Xaloc 6 SE DECISION MADE: 05-FEB-18
Sabadell ES 08203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gammex PI Breach Detect Powder Free Surgical Glove
Ansell Healthcare Products LLC 510(k) NO: K171375(Traditional)
ATTN: Robert Mahler PHONE NO : 732 3452174
111 Wood Avenue South, Suite 210 SE DECISION MADE: 06-FEB-18
Iselin NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Micromed BRAIN QUICK system
Micromed S.P.A 510(k) NO: K171384(Traditional)
ATTN: Monica Camillo PHONE NO : 39 041 593700
Via Giotto 2 SE DECISION MADE: 01-FEB-18
Mogliano Veneto IT 31021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ Slim Nasopharyngolaryngoscope
KARL STORZ Endoscopy-America, Inc.510(k) NO: K171402(Traditional)
ATTN: AnnaLisa Smullin PHONE NO : 424 2188376
2151 E. Grand Avenue SE DECISION MADE: 02-FEB-18
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OralTox Oral Fluid Drug Test
Premier Biotech Inc 510(k) NO: K171403(Traditional)
ATTN: Jacqueline Gale PHONE NO : 888 6869909
723 Kasota Avenue SE SE DECISION MADE: 02-FEB-18
Minneapolis MN 55414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glooko Mobile Insulin Dosing System
Glooko, Inc 510(k) NO: K171450(Traditional)
ATTN: Tejasvi Pasi PHONE NO : 650 7205310
899 West Evelyn Avenue SE DECISION MADE: 02-FEB-18
Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT-6XX Series Infrared Thermometer
Xiamen Acurio Instruments Co., Ltd510(k) NO: K171455(Traditional)
ATTN: Angel Liu PHONE NO : 86 592 6312776
3rd-4th Floors, BI Park, No.2028 WSE DECISION MADE: 09-FEB-18
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
Awareness Technology, Inc. 510(k) NO: K171476(Traditional)
ATTN: Steve Andrus PHONE NO : 772 2836540
1935 S.W Martin Hwy. SE DECISION MADE: 27-FEB-18
Palm City FL 34990 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zyston Strut Open Titanium Spacer System
Zimmer Biomet Spine Inc. 510(k) NO: K171495(Traditional)
ATTN: Megan Fessenden PHONE NO : 303 4658994
10225 Westmoor Drive SE DECISION MADE: 12-FEB-18
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flip Lube
Imquest Biosciences Inc. 510(k) NO: K171516(Traditional)
ATTN: Karen W. Buckheit PHONE NO : 301 6960274
7340 Executive Way, Suite R SE DECISION MADE: 05-FEB-18
Frederick MD 21704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SteriZign Signatur Device Protection System
SteriZign Precision Technologies, 510(k) NO: K171520(Traditional)
ATTN: Sonia Lutarewych PHONE NO : 206 5103650
74 Orion Street SE DECISION MADE: 07-FEB-18
Brunswick ME 04011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUS R-50S (Urine Chemistry system)
DFI Co., Ltd. 510(k) NO: K171521(Traditional)
ATTN: Bella Cho PHONE NO : 88 55 3461882
388-25, Gomo-ro, Jillye-myeon, GimSE DECISION MADE: 16-FEB-18
Gyeongsangnam-do KR 621-881 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL ISOLATION GOWN
Jingzhou Haixin Green Cross Medica510(k) NO: K171535(Traditional)
ATTN: Rarda L PHONE NO : 86 27 82836720
Room 916-918, Floor 9, InternationSE DECISION MADE: 15-FEB-18
Wuhan CN 430015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQRef Introducer Sheath
Acutus Medical, Inc. 510(k) NO: K171557(Traditional)
ATTN: Brenda Clay PHONE NO : 1 442 2326080
2210 Faraday Ave., Suite 100 SE DECISION MADE: 06-FEB-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
Hans Biomed Corporation 510(k) NO: K171568(Traditional)
ATTN: Lucy Choi PHONE NO : 82 246 62266
64, Yuseong-daero 1628 beon-gil YuSE DECISION MADE: 22-FEB-18
Daejeon KR 34054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Panthera Anti-Snoring X3 Device
Panthera Dental Inc. 510(k) NO: K171576(Abbreviated)
ATTN: Martine Fortin PHONE NO : 418 5270388
2035, rue du Haut-Bord SE DECISION MADE: 22-FEB-18
Quebec city CA G1N 4N7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renal Access Cobra Catheter, Kumpe Access Catheter
Cook Incorporated 510(k) NO: K171600(Traditional)
ATTN: Samuel Engelman PHONE NO : 812 3392235 104340
750 Daniels Way SE DECISION MADE: 16-FEB-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultraxx Nephrostomy Balloon Catheter
Cook Incorporated 510(k) NO: K171601(Traditional)
ATTN: Minjin Choi PHONE NO : 812 3392235 104901
750 Daniels Way SE DECISION MADE: 23-FEB-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
Cook Incorporated 510(k) NO: K171604(Traditional)
ATTN: Ian Herrman PHONE NO : 812 3353575 104034
450 Daniels Way, P.O. Box 489 SE DECISION MADE: 15-FEB-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys CA 15-3 II
Roche Diagnostics 510(k) NO: K171605(Traditional)
ATTN: Adennis Cora PHONE NO : 317 5213915
9115 Hague Road SE DECISION MADE: 20-FEB-18
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PiCCO Catheter
PULSION Medical Systems SE 510(k) NO: K171620(Traditional)
ATTN: Ingrid Rohm PHONE NO : 49 89 4599140
Hans-Riedl-Strasse 17 SE DECISION MADE: 21-FEB-18
Feldkirchen DE 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABCcolla Bone Graft
ACRO Biomedical Co., Ltd. 510(k) NO: K171629(Traditional)
ATTN: Dar-Jen Hsieh PHONE NO : 886 769 55569
3F., No.57, Luke 2nd Rd., Lujhu DiSE DECISION MADE: 01-FEB-18
Kaohsiung City TW 82151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standard Catheter Set
Varian Medical Systems, Inc. 510(k) NO: K171631(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246230
3100 Hansen Way SE DECISION MADE: 09-FEB-18
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OpClear System
Cipher Surgical Ltd 510(k) NO: K171637(Traditional)
ATTN: Justin Buch PHONE NO : 44 2477 170707
The Venture Centre, Sir William LySE DECISION MADE: 26-FEB-18
Coventry GB CV4 7EZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accula Flu A/Flu B Test
Mesa Biotech, Inc. 510(k) NO: K171641(Dual Track)
ATTN: Barbara E. Stevens PHONE NO : 858 7355043
6190 Cornerstone Court, Suite 220 SE DECISION MADE: 06-FEB-18
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIST|CVi® Contrast Delivery System
ACIST Medical Systems, Inc. 510(k) NO: K171646(Traditional)
ATTN: Melissa Sommerfeld PHONE NO : 952 9959300
7905 Fuller Road SE DECISION MADE: 16-FEB-18
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann CARES M-Series CAD/CAM System
Institut Straumann AG 510(k) NO: K171649(Traditional)
ATTN: Andreas Petermann PHONE NO : 41 61 9651482
Peter Merian Weg 12 SE DECISION MADE: 22-FEB-18
Basel CH 4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter
Cook Incorporated 510(k) NO: K171662(Traditional)
ATTN: Carly Powell PHONE NO : 812 3392235 104913
750 Daniels Way SE DECISION MADE: 01-FEB-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bluetooth blood pressure monitor
Visiomed Group SA 510(k) NO: K171668(Traditional)
ATTN: Eric Sebban PHONE NO : 33 140 670667
112 Av. Kleber SE DECISION MADE: 26-FEB-18
Paris FR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prismaflex System 8.10
Baxter Healthcare Corporation 510(k) NO: K171671(Traditional)
ATTN: Rick Lukacovic PHONE NO : 224 2702476
32650 North Wilson Road SE DECISION MADE: 23-FEB-18
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana
W.H.P.M., Inc. 510(k) NO: K171695(Traditional)
ATTN: John Wan PHONE NO : 626 4438480
5358 Irwindale Ave. SE DECISION MADE: 05-FEB-18
Irwindale CA 91706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
Omega Medical Imaging, LLC 510(k) NO: K171755(Special)
ATTN: John Newman PHONE NO : 407 3239400
675 Hickman Circle SE DECISION MADE: 09-FEB-18
Sanford FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRYPTIK2 C-Plate Anterior Cervical Plate System
Spineart 510(k) NO: K171797(Traditional)
ATTN: Franck Pennesi PHONE NO : 41 225 701200
3 chemin du pre Fleuri SE DECISION MADE: 26-FEB-18
Plan Les Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U&U Indicator tape and strip
U&U Medical Technology Co., Ltd 510(k) NO: K171823(Traditional)
ATTN: Xuebo Wang PHONE NO : 86 135 64751751
Dongzhou Village Hengshanqiao SE DECISION MADE: 22-FEB-18
Changzhou CN 213119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
Hunan Handlike Minimally Invasive 510(k) NO: K171825(Traditional)
ATTN: Hu hanhan PHONE NO : 86 731 89783577
A4, Lugu Yuyuan, #27, Wenxuan Rd HSE DECISION MADE: 13-FEB-18
Changsha CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPILLARYS Hb A1c
Sebia 510(k) NO: K171861(Traditional)
ATTN: Karen Anderson PHONE NO : 770 4463707
1705 Corporate Drive Suite 400 SE DECISION MADE: 07-FEB-18
Norcross GA 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sutter CURIS RF Generator
Sutter Medizintechnik GmbH 510(k) NO: K171869(Traditional)
ATTN: Ulrike Zeissler PHONE NO : 49 0761 5155114
Tullastrasse 87 SE DECISION MADE: 23-FEB-18
Freiburg DE 79108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
Asahi Intecc Co., Ltd. 510(k) NO: K171933(Traditional)
ATTN: Yasuyuki Kawahara PHONE NO : 81 52 7681211
1703 Wakita-cho, Moriyama-Ku SE DECISION MADE: 12-FEB-18
Nagoya JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silicone Peripherally Inserted Central Venous Catheter Set/Tray
Cook Incorporated 510(k) NO: K171994(Traditional)
ATTN: Johnathan Liu PHONE NO : 1 812 3353575 104509
750 Daniels Way SE DECISION MADE: 22-FEB-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICO 7 Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited 510(k) NO: K172005(Traditional)
ATTN: Samantha Neilson PHONE NO : 44 148 2673790
101 Hessle Road SE DECISION MADE: 02-FEB-18
Hull GB hu3 2bn 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilex Fluid Control System AQL-100S
W.O.M. World Of Medicine GmbH 510(k) NO: K172040(Special)
ATTN: Lucia Puetmann PHONE NO : 011 4930 39981594
Salzufer 8 SE DECISION MADE: 05-FEB-18
Berlin DE 10587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroNav System, NeuroSmart System
Alpha Omega Engineering Ltd. 510(k) NO: K172042(Traditional)
ATTN: Maysana Mousa PHONE NO : 972 4 6563327
Nazareth Industrial Park, Mount PrSE DECISION MADE: 27-FEB-18
Nazareth IL 1612102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action Stent Introduction System with preloaded Cotton-Leung Biliary Stent, Oasis One Action Stent Introduction System with preloaded Soehendra Tannenbaum Biliary Stent Set
Cook Ireland Ltd 510(k) NO: K172044(Traditional)
ATTN: Laura Graham PHONE NO : 011 353 61334440
O'Halloran Road, National TechnoloSE DECISION MADE: 27-FEB-18
Limerick IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT6485, CT12885
Analogic Corporation 510(k) NO: K172058(Traditional)
ATTN: Karen Provencher PHONE NO : 978 3264668
8 Centennial Drive SE DECISION MADE: 13-FEB-18
Peabody MA 01960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Plateau-LO Spacer System
Life Spine Inc. 510(k) NO: K172105(Traditional)
ATTN: Randy Lewis PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 02-FEB-18
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERISTEEL
M/s. Meril Endo Surgery Private Li510(k) NO: K172146(Traditional)
ATTN: Umesh Sharma PHONE NO : 91 0260 3052100
Third Floor, E1-E3, Meril Park SurSE DECISION MADE: 01-FEB-18
Chala, Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Southern Implants PEEK Abutments
Southern Implants (Pty) Ltd 510(k) NO: K172160(Traditional)
ATTN: Lauranda Breytenbach PHONE NO : 27 12 6771046
1 Albert Street SE DECISION MADE: 09-FEB-18
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSCAR 15
Genoray Co.,Ltd 510(k) NO: K172180(Traditional)
ATTN: Ji-Yeon Choi PHONE NO : 82 31 6273953
512, 560, Dunchon-daero, Jungwon-gSE DECISION MADE: 09-FEB-18
Seongnam-si KR 13230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
NeVap, Inc. 510(k) NO: K172208(Traditional)
ATTN: Brenton Hanlon PHONE NO :
975 Dionne Way SE DECISION MADE: 16-FEB-18
San Jose CA 95133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bicera Resorbable Bone Substitute
Wiltrom Corporation Limited 510(k) NO: K172237(Traditional)
ATTN: Yi-Chun Su PHONE NO : 886 3 6107168
1F., No. 26, Sec. 2, Shengyi Rd. SE DECISION MADE: 02-FEB-18
Zhubei City TW 30261 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAPA LP-15 Airway Pressure Monitor
DRW Medical, LLC 510(k) NO: K172284(Traditional)
ATTN: Dan Tatum PHONE NO : 1 800 2306002
811 Lincoln Drive SE DECISION MADE: 09-FEB-18
Brookhaven PA 19015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Osteotomy Truss System (OTS)
4Web, Inc. 510(k) NO: K172294(Traditional)
ATTN: Jessee Hunt PHONE NO : 800 2857090
2801 Network Blvd. Suite 620 SE DECISION MADE: 22-FEB-18
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neurostructures Cavetto® Cervical Cage System
NeuroStructures, Inc. 510(k) NO: K172320(Traditional)
ATTN: Kathleen Wong PHONE NO : 949 3704497
16 Technology Drive Suite 165 SE DECISION MADE: 26-FEB-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axiostat Chitosan Hemostatic Dressing
Advamedica Inc. 510(k) NO: K172324(Traditional)
ATTN: Leo Mavely PHONE NO : 973 7187575
485 Massachusetts Avenue, Suite 30SE DECISION MADE: 23-FEB-18
Cambridge MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catasyn Advanced Technology Wound Hydrogel
Synedgen, Inc 510(k) NO: K172338(Traditional)
ATTN: Shenda Baker PHONE NO : 1 909 4476858
1420 N. Claremont Blvd., Suite 105SE DECISION MADE: 21-FEB-18
Claremont CA 91711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
Aesku Diagnostics GmbH & Co. KG 510(k) NO: K172348(Traditional)
ATTN: Sandra Reuter PHONE NO : 49 673 496220
Mikro-Forum-Ring 2 SE DECISION MADE: 16-FEB-18
Wendeslheim DE 55234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEA Circular Stapler with Tri-Staple Technology
Covidien 510(k) NO: K172361(Traditional)
ATTN: Sarah Tang PHONE NO : 86 21 33230158
Rooms 501, 502, 601, 602 No.3 builSE DECISION MADE: 16-FEB-18
Min Hang District, Shanghai CN 20510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optima Coil System
Blockade Medical, LLC (d.b.a. Balt510(k) NO: K172390(Traditional)
ATTN: Rebecca K. Pine PHONE NO : 760 8095178
18 Technology Dr. Ste 169 SE DECISION MADE: 18-FEB-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Duatene bilayer mesh
Sofradim Production 510(k) NO: K172395(Traditional)
ATTN: Benjamin Rochette PHONE NO : 33 4 74089000
116 avenue du Formans SE DECISION MADE: 01-FEB-18
Trevoux FR 01600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kohli Urinary Drainage Catheter
Nellie Medical, LLC 510(k) NO: K172422(Traditional)
ATTN: Ronald Adams PHONE NO : 775 8007300
18 Hillside Drive SE DECISION MADE: 09-FEB-18
Holliston MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
Edwards Lifescience LLC 510(k) NO: K172423(Traditional)
ATTN: Bedalin T. Lugo Rodriguez PHONE NO : 787 2295433
One Edwards Way SE DECISION MADE: 20-FEB-18
Ivine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Siberian Fit
Vydence 510(k) NO: K172439(Traditional)
ATTN: Kevin Walls PHONE NO : 720 96 25412
Rua Aldo Germano Klein, 359 Cep: 1SE DECISION MADE: 14-FEB-18
Sao Carlos/ Sp Sao Paulo BR 13.57510(k) STATEMENT
DEVICE: eUnity
Client Outlook Inc. 510(k) NO: K172490(Traditional)
ATTN: Christie Eby PHONE NO : 519 3423049 206
103 Bauer Place, Suite #3 SE DECISION MADE: 06-FEB-18
Waterloo CA N2T 2V2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tosama Biobased Applicator Tube Menstrual Tampon
TOSAMA, d.o.o. 510(k) NO: K172504(Traditional)
ATTN: Marjetka Kralj Kuncic PHONE NO : 00386 1 7290370
Saranoviceva cesta 35 SE DECISION MADE: 09-FEB-18
Vir SI 1230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sentosa SA201 HSV 1/2 Qualitative PCR Test
Vela Diagnostics USA Inc. 510(k) NO: K172509(Traditional)
ATTN: Donald Henton PHONE NO : 973 3693578
353C US Route 46 West Suite 250 SE DECISION MADE: 01-FEB-18
Fairfield NJ 07004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRO HCG Pregnancy Rapid Test
ACRO Biotech, Inc. 510(k) NO: K172512(Special)
ATTN: Joseph Fan PHONE NO : 909 4666892
9500 Seventh Street, Suite M SE DECISION MADE: 02-FEB-18
Rancho Cucamonga CA 91730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Catheter Specimen Collector
Medline Industries, Inc. 510(k) NO: K172541(Traditional)
ATTN: Dinah Rincones PHONE NO : 847 9792687
Three Lakes Drive SE DECISION MADE: 22-FEB-18
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
The Binding Site Group Ltd. 510(k) NO: K172613(Traditional)
ATTN: Andrea Thomas PHONE NO : 44 0121 4569500
8 Calthorpe Road, Edgbaston SE DECISION MADE: 15-FEB-18
Birmingham GB B15 1QT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant 5mm Fusion Device
Applied Medical Resources Corporat510(k) NO: K172624(Special)
ATTN: Andrew Nguyen PHONE NO : 949 7135458
22872 Avenida Empresa SE DECISION MADE: 13-FEB-18
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed ArthroCare ENT Coblator
ReNovo, Inc. 510(k) NO: K172647(Traditional)
ATTN: Mark K. Wells PHONE NO : 1 541 4228880
340 SW Columbia St SE DECISION MADE: 21-FEB-18
Bend OR 97702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-Beam Fusion Beaming System
Orthofix Srl 510(k) NO: K172698(Traditional)
ATTN: Gianluca Ricadona PHONE NO : 39 045 6719000
SE DECISION MADE: 07-FEB-18
Bussolengo IT 37012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
STERIS Corporation 510(k) NO: K172746(Abbreviated)
ATTN: Bill Brodbeck PHONE NO : 440 3542600
5960 Heisley Road SE DECISION MADE: 09-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
STERIS Corporations 510(k) NO: K172748(Traditional)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 09-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vis-U-All Low Temperature Sterilization Pouch/Tubing
Steris Corporation 510(k) NO: K172749(Traditional)
ATTN: Tricia Cregger PHONE NO : 440 3927189
5960 Heisley Road SE DECISION MADE: 09-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)
Guangzhou Sonostar Technologies Co510(k) NO: K172750(Abbreviated)
ATTN: Weizhong Cai PHONE NO : 86 20 32382095
504#, C Building,#27 Yayingshi RoaSE DECISION MADE: 28-FEB-18
Guangzhou CN 510665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iVitri Straw
Reprobitech Corp. 510(k) NO: K172751(Traditional)
ATTN: Huai L. Feng PHONE NO : 516 3016171
42-31 Colden St., Suite 202 SE DECISION MADE: 09-FEB-18
Flushing NY 11355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELERITY 20 HP Biological Indicator
Steris Corporation 510(k) NO: K172752(Traditional)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 09-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY VH2O2 Indicator Tape
Steris Corporation 510(k) NO: K172753(Traditional)
ATTN: Bill Brodbeck PHONE NO : 440 3927960
5960 Heisley Road SE DECISION MADE: 09-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-PRO maX 2 Low Temperature Sterilization System
Steris Corporation 510(k) NO: K172754(Traditional)
ATTN: Bill Brodbeck PHONE NO : 440 3542600
5960 Heisley Road SE DECISION MADE: 09-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-LITE Sterilization Trays
Steris Corporation 510(k) NO: K172755(Traditional)
ATTN: Tricia Cregger PHONE NO : 440 3927189
5960 Heisley Road SE DECISION MADE: 09-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
Teleflex Medical, Inc. 510(k) NO: K172775(Traditional)
ATTN: Holly Hallock PHONE NO : 919 4334918
3015 Carrington Mill Blvd SE DECISION MADE: 12-FEB-18
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Specimen Retrieval Bag
Beijing HangTian KaDi Technology R510(k) NO: K172789(Traditional)
ATTN: Liying Zhang PHONE NO : 86 10 56407751
Room301-11, Third floor, Building SE DECISION MADE: 01-FEB-18
Beijing CN 101102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECG Cable/Leadwires
Shenzhen Coreray Technology., Ltd 510(k) NO: K172797(Traditional)
ATTN: Simon Fan PHONE NO : 86 755 28239229
ChuangYe Technology Park,1th Dong SE DECISION MADE: 28-FEB-18
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Double Medical Cage System
Double Medical Technology Inc 510(k) NO: K172828(Traditional)
ATTN: Yan Zuo PHONE NO : 86 592 6087671
No. 18 Shanbianhong East Road, HaiSE DECISION MADE: 01-FEB-18
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insight BD
Siemens Medical Solutions, Inc 510(k) NO: K172832(Traditional)
ATTN: Denise Adams PHONE NO : 610 4486139
40 Liberty Boulevard 65-1A SE DECISION MADE: 06-FEB-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSOLV
Septodont 510(k) NO: K172839(Traditional)
ATTN: Jaimie Woodruff PHONE NO : 303 6657535 6270
416 South Taylor Avenue SE DECISION MADE: 13-FEB-18
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
The Binding Site Group Ltd. 510(k) NO: K172868(Traditional)
ATTN: Kirsty Samuels PHONE NO : 44 0121 4569500
8 Calthorpe Road, Edgbaston SE DECISION MADE: 28-FEB-18
Birmingham GB B15 1QT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
Hangzhou Hua'an medical&health ins510(k) NO: K172870(Special)
ATTN: Ahneo Yang PHONE NO : 86 571 88734065
Building 2, 1# Fuzhu Nan RD, WuchaSE DECISION MADE: 13-FEB-18
Hangzhou CN 310023 510(k) STATEMENT
DEVICE: Home Use Hair Removal Device/T1, T2, T3
Shenzhen Mareal Tech Co., Ltd 510(k) NO: K172883(Traditional)
ATTN: Libin Liu PHONE NO : 86 188 22881173
403A Block, Xinlong Technology ParSE DECISION MADE: 12-FEB-18
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HydroPICC
Access Vascular, Inc 510(k) NO: K172885(Traditional)
ATTN: Elizabeth Kinnal PHONE NO : 978 6187945
175 Middlesex Turnpike SE DECISION MADE: 20-FEB-18
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vygon PICCs
Vygon USA 510(k) NO: K172899(Traditional)
ATTN: Jillian Mikovich PHONE NO : 800 4735414
2750 Morris Rd Suite A200 SE DECISION MADE: 26-FEB-18
Lansdale PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Needle Free Transseptal Cannula
Pressure Products Medical Device M510(k) NO: K172934(Traditional)
ATTN: Andrew Armour PHONE NO : 610 5432324
1 School Street SE DECISION MADE: 16-FEB-18
Morton PA 19070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASCADIA Interbody System
K2M 510(k) NO: K172941(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
600 Hope Parkway SE SE DECISION MADE: 12-FEB-18
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSN Transseptal Needle
Pressure Products Medical Device M510(k) NO: K172950(Traditional)
ATTN: Andrew Armour PHONE NO : 610 5432324
1 School Street SE DECISION MADE: 21-FEB-18
Morton PA 19070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acid Etchant
American Orthodontics 510(k) NO: K172953(Traditional)
ATTN: Trang Adams PHONE NO : 920 4575051
3524 Washington Avenue SE DECISION MADE: 06-FEB-18
Sheboygan WI 53081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System
NuVasive, Incorporated 510(k) NO: K173025(Traditional)
ATTN: Cynthia Adams PHONE NO : 858 3204549
7475 Lusk Blvd. SE DECISION MADE: 08-FEB-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Solstice OCT System
Life Spine, Inc. 510(k) NO: K173047(Traditional)
ATTN: Randy Lewis PHONE NO : 847 8846117
13951 S. Quality Drive SE DECISION MADE: 01-FEB-18
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightForce LTS Model 1000, 1500, 2500, and 4000
LiteCure, LLC 510(k) NO: K173067(Traditional)
ATTN: Eric Rock PHONE NO : 302 7090408
250 Corporate Blvd. Suite B SE DECISION MADE: 22-FEB-18
Newark DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cavetto-SA Cervical Cage System
NeuroStructures, Inc. 510(k) NO: K173077(Traditional)
ATTN: Kathleen Wong PHONE NO : 949 3704497
16 Technology Drive Suite 165 SE DECISION MADE: 23-FEB-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CereMetrix Silver
CereMetrix Corp 510(k) NO: K173145(Traditional)
ATTN: John A Kelley PHONE NO : 720 2591875
991 Southpark Drive , Suite 200 SE DECISION MADE: 28-FEB-18
Littleton CO 80120 510(k) STATEMENT
DEVICE: ChlorCid, ChlorCid V, ChlorCid Surf
Ultradent Products, Inc. 510(k) NO: K173163(Traditional)
ATTN: Corey Jaseph PHONE NO : 801 5534420
505 W Ultradent Drive (10200 SouthSE DECISION MADE: 09-FEB-18
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEURAT™ Universal Pedicle Screw System
CTL Medical Corporation 510(k) NO: K173185(Traditional)
ATTN: Tosan Onosode PHONE NO : 214 5455820
4550 Excel Parkway, Suite 300 SE DECISION MADE: 14-FEB-18
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
Everyway Medical Instruments Co., 510(k) NO: K173186(Special)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3Fl., No. 5, Lane 155, Sec. 3, BeiSE DECISION MADE: 28-FEB-18
New Taipei City TW 22203 510(k) STATEMENT
DEVICE: DRI Hydrocodone Assay
Microgenics Corporation 510(k) NO: K173195(Traditional)
ATTN: Minoti Patel PHONE NO : 510 9795000
46500 Kato Road SE DECISION MADE: 13-FEB-18
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PicoSure Workstation
Cynosure, Inc 510(k) NO: K173199(Traditional)
ATTN: Avinash Purohit PHONE NO : 978 3672450
5 Caelisle Road SE DECISION MADE: 07-FEB-18
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd 510(k) NO: K173204(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
42, Teheran-ro 108-gil SE DECISION MADE: 05-FEB-18
Seoul KR 06176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instant-view-PLUS immunochemical Fecal Occult Blood Test
Alfa Scientific Designs, Inc. 510(k) NO: K173212(Traditional)
ATTN: Wen Hua Fan PHONE NO : 858 3665156
13200 Gregg St SE DECISION MADE: 15-FEB-18
Poway CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIN-SWI
SpinTech, Inc. 510(k) NO: K173224(Traditional)
ATTN: Kay Fuller PHONE NO : 734 8467852
30200 Telegraph Road Suite 140 SE DECISION MADE: 23-FEB-18
Bingham Farms MI 48025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-MED Powder Free Polyethylene Examination Gloves,Blue Color
Jiangsu U-MED Rubber & Plastic Pro510(k) NO: K173228(Traditional)
ATTN: Chen Ye PHONE NO :
Luzhuang Road, Suyu High-Tech ZoneSE DECISION MADE: 20-FEB-18
Suqian CN 223804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sentry IVC Filter
Novate Medical Ltd. 510(k) NO: K173236(Traditional)
ATTN: Gordon Crowley PHONE NO : 353 91 750030
Block 11, Galway Technology Park PSE DECISION MADE: 22-FEB-18
Galway IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: superDimension Navigation System V7.2
Covidien LLC 510(k) NO: K173244(Traditional)
ATTN: Kristi Fox PHONE NO : 763 6475553
161 Cheshire Lane, Suite 100 SE DECISION MADE: 08-FEB-18
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Talon DistalFix Humeral Nail
Orthopedic Designs North America, 510(k) NO: K173255(Traditional)
ATTN: Robin Wilson PHONE NO : 888 6358535
5912 Breckenridge Parkway Suite F SE DECISION MADE: 22-FEB-18
Tampa FL 33610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tri-Staple 2.0 Reinforced Reload
Covidien 510(k) NO: K173270(Traditional)
ATTN: Rebecca Magnanimo PHONE NO : 203 4926479
60 Middletown Ave. SE DECISION MADE: 20-FEB-18
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ergonomic Handle
Symmetry Surgical Inc. 510(k) NO: K173272(Traditional)
ATTN: Christopher Smith PHONE NO : 615 8839090
3034 Owen Drive SE DECISION MADE: 09-FEB-18
Antioch TN 37013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNICHROMA
Tokuyama Dental Corporation 510(k) NO: K173275(Traditional)
ATTN: Keith A. Barritt PHONE NO : 011 813 38352261
38-9 Taitou 1-chome, Taitou-ku SE DECISION MADE: 27-FEB-18
Tokyo JP 110-0016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorPath GRX System
Corindus, Inc. 510(k) NO: K173288(Traditional)
ATTN: Robert Lavado PHONE NO : 508 6533335 211
309 Waverley Oaks Road SE DECISION MADE: 15-FEB-18
Waltham MA 02452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
Alfa Scientific Designs, Inc 510(k) NO: K173303(Traditional)
ATTN: Naishu Wang PHONE NO : 858 5133888
13200 Gregg Street SE DECISION MADE: 23-FEB-18
Poway CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "SupaChair" Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
Eurogreen International Inc. 510(k) NO: K173313(Traditional)
ATTN: David Hsieh PHONE NO : 886 4 8319633
No. 48, Lane 220, Sec. 1, Fu-Zun RSE DECISION MADE: 13-FEB-18
Chang-Hua County CN 51055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "SupaChair" Powered Wheelchair
Eurogreen International Inc. 510(k) NO: K173315(Traditional)
ATTN: David Hsieh PHONE NO : 886 4 8319633
No. 48, Lane 220, Sec 1, Fu-Zun RdSE DECISION MADE: 13-FEB-18
Chang-Hua County CN 51055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin L1 MMF System
KLS Martin LP 510(k) NO: K173320(Traditional)
ATTN: Jennifer Damato PHONE NO : 800 6251557
11201 Saint Johns Industrial ParkwSE DECISION MADE: 23-FEB-18
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTA Anterior Cervical Interbody Spacer
Astura Medical 510(k) NO: K173324(Traditional)
ATTN: Thomas Purcell PHONE NO : 760 8148047
3186 Lionshead Ave, Suite 100 SE DECISION MADE: 27-FEB-18
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Spinous Process System
SeaSpine Orthopedics Corporation 510(k) NO: K173334(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 22-FEB-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gazelle PTFE and Suture Delivery Device
Dura Tap LLC 510(k) NO: K173335(Abbreviated)
ATTN: Ann R. Lee PHONE NO : 1 215 5864714
208 Upland Way SE DECISION MADE: 08-FEB-18
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zygomatic Implant System
Southern Implants (Pty) Ltd 510(k) NO: K173343(Traditional)
ATTN: Lauranda G. Breytenbach PHONE NO : 27 12 6671046
1 Albert Road SE DECISION MADE: 27-FEB-18
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
Concentric Medical, Inc. 510(k) NO: K173352(Traditional)
ATTN: Rhoda M. Santos PHONE NO : 510 4132269
301 East Evelyn Avenue SE DECISION MADE: 15-FEB-18
Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MC 300* Nebulizer
Trudell Medical International 510(k) NO: K173367(Traditional)
ATTN: Marianne Tanton PHONE NO : 1 519 4557060
725 Third Street SE DECISION MADE: 28-FEB-18
London CA n5V 5G4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nexxis OR
Barco n.v. 510(k) NO: K173381(Special)
ATTN: Eric Caus PHONE NO : 32 56 233349
Beneluxpark 21 SE DECISION MADE: 22-FEB-18
Kortrijk BE 8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORISE Tissue Retractor System
Boston Scientific 510(k) NO: K173400(Traditional)
ATTN: Thomas Hirte PHONE NO : 508 6834454
100 Boston Scientific Way SE DECISION MADE: 09-FEB-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neocis Guidance System (NGS) with Chairside Splint
Neocis Inc 510(k) NO: K173402(Traditional)
ATTN: Alon Mozes PHONE NO : 305 4092819
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 22-FEB-18
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Audio System
NeoCoil, LLC 510(k) NO: K173409(Traditional)
ATTN: Michael Leigh PHONE NO : 262 5226127
N27 W23910A Paul Rd. SE DECISION MADE: 16-FEB-18
Pewaukee WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comprehensive Segmental Revision System (SRS)
Biomet Manufacturing Corp. 510(k) NO: K173411(Traditional)
ATTN: Patricia Sandborn Beres PHONE NO : 574 2676639
56 East Bell Drive SE DECISION MADE: 08-FEB-18
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProxiDiagnost N90
Philips Medical Systems DMC GmbH 510(k) NO: K173433(Traditional)
ATTN: Ming Xiao PHONE NO : 49 40 50782306
Roentgenstrasse 24-26 SE DECISION MADE: 05-FEB-18
Hamburg DE 22335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Rapid Readout Biological Indicator
3M Company 510(k) NO: K173435(Traditional)
ATTN: Nadia Battah PHONE NO : 651 7330929
3M Center, Building 275-5W-06 SE DECISION MADE: 09-FEB-18
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEON Endoscopic Stapler
Lexington Medical Inc. 510(k) NO: K173443(Traditional)
ATTN: Donna Gasper PHONE NO : 617 2099817
11 Executive Park Drive SE DECISION MADE: 01-FEB-18
Billerica MA 01862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise TKA Guide System
Materialise NV 510(k) NO: K173445(Traditional)
ATTN: Oliver Clemens PHONE NO : 32 16 396280
Technologielaan 15 SE DECISION MADE: 02-FEB-18
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESS DUO elite, PRESS DUO elite AG
Nemoto Kyorindo Co., Ltd. 510(k) NO: K173450(Traditional)
ATTN: Jim Knipfer PHONE NO : 81 3 58428571
2-27-20 Hongo SE DECISION MADE: 07-FEB-18
Bunkyo-ku JP 113-0033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroEEG
MemoryMD Inc. 510(k) NO: K173460(Traditional)
ATTN: Abdus-Salaam Muwwakkil PHONE NO : 215 3416373
205 East 42nd St 14th FL SE DECISION MADE: 16-FEB-18
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
Toshiba Medical Systems Corporatio510(k) NO: K173468(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 23-FEB-18
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amsco Evolution Medium Steam Sterilizer
STERIS Corporation 510(k) NO: K173485(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 22-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
STERIS Corporation 510(k) NO: K173490(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 22-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTS Lesser MTP Implant System
In2Bones USA, LLC 510(k) NO: K173491(Traditional)
ATTN: Rebecca Wahl PHONE NO :
6060 Poplar Ave, Suite 380 SE DECISION MADE: 23-FEB-18
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000
STERIS Corporation 510(k) NO: K173493(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 23-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Meridian Vaginal Positioning System (VPS)
Coloplast 510(k) NO: K173501(Traditional)
ATTN: Diane Brinza PHONE NO : 612 9798983
1601 West River Road North SE DECISION MADE: 09-FEB-18
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MFI-Cardiac
MultiFunctional Imaging, LLC 510(k) NO: K173512(Traditional)
ATTN: Dan Kadrmas PHONE NO : 801 9535655
551 E 50 N SE DECISION MADE: 05-FEB-18
North Salt Lake UT 84054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K173513(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
42, Teheran-ro 108-gil SE DECISION MADE: 20-FEB-18
Seoul KR 06176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)
Becton, Dickinson and Company 510(k) NO: K173523(Traditional)
ATTN: Monica E. Giguere PHONE NO : 410 3164287
7 Loveton Circle MC 694 SE DECISION MADE: 09-FEB-18
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digitex Delivery Device
Coloplast A/S 510(k) NO: K173527(Traditional)
ATTN: Nikita Basandra PHONE NO : 612 5058779
1601 West River Road North SE DECISION MADE: 12-FEB-18
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
Devon Medical Products (Jiangsu) L510(k) NO: K173528(Special)
ATTN: Julian Chu PHONE NO : 86 513 51080988
East Half of 1-2f, Appt D2 1, QingSE DECISION MADE: 06-FEB-18
Nantong CN 226017 510(k) STATEMENT
DEVICE: Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device
Titan Spine, LLC 510(k) NO: K173535(Special)
ATTN: Jane Rodd PHONE NO : 262 2427801
6140 W. Executive Dr., Suite A SE DECISION MADE: 13-FEB-18
Mequon WI 53092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCORDE LIFT™
Medos International, SARL 510(k) NO: K173537(Traditional)
ATTN: Karen Sylvia PHONE NO : 508 9773804
Chemin-Blanc 38 SE DECISION MADE: 08-FEB-18
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMED Gas Diffuser
TEMED 510(k) NO: K173545(Traditional)
ATTN: Katie Evans PHONE NO : 44 1243572255
Unit 3, Keynor Farm SE DECISION MADE: 14-FEB-18
Sidlesham GB PO20 7LL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUCAS 3 Chest Compression System
Jolife AB 510(k) NO: K173553(Traditional)
ATTN: Malin Melander PHONE NO : 46 46 2865000
Scheelevagen 17 Ideon Science ParkSE DECISION MADE: 08-FEB-18
Lund SE 22370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Patient Examination Glove (Yellow)
Yurun Glove Co., Ltd. 510(k) NO: K173561(Traditional)
ATTN: Chao Kevin PHONE NO : 86 315 4168700
No. 10 Zhaocai Street, Luannan CouSE DECISION MADE: 12-FEB-18
ShiTangShan CN 063000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sunrise 6200, Sunrise 7200
JK-Holding GmbH 510(k) NO: K173565(Traditional)
ATTN: Juergen Gerstenmeier PHONE NO : 49 0 2224818330
Koehlershohner Strasse 60 SE DECISION MADE: 14-FEB-18
Windhagen DE 53578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sera
Interacoustics A/S 510(k) NO: K173567(Traditional)
ATTN: Amy Yanta PHONE NO :
Audiometer Alle 1 SE DECISION MADE: 14-FEB-18
Middelfart DK 5500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasound System 1300
BK Medical ApS 510(k) NO: K173569(Abbreviated)
ATTN: Karen Provencher PHONE NO : 978 3264668
Mileparken 34 SE DECISION MADE: 23-FEB-18
Herlev DK 2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thorecon™ Fixation System
A&E Medical Corporation 510(k) NO: K173579(Traditional)
ATTN: Dana Rodriguez PHONE NO : 732 9382266
5206 Asbury Road, PO Box 758 SE DECISION MADE: 12-FEB-18
Farmingdale NJ 07727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Patient Examination Glove (Yellow)
Nature Medical Products Co.,Ltd. 510(k) NO: K173580(Traditional)
ATTN: Chao Kevin PHONE NO : 86 315 4168700
No.7 West Street, Sigezhuang Town SE DECISION MADE: 15-FEB-18
BenCheng CN 063000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magseed Magnetic Marker Systtem
Endomagnetics Ltd. 510(k) NO: K173587(Traditional)
ATTN: Andrew Shawcross PHONE NO : 440 1223 652540
The Jeffreys Building, Cowley RoadSE DECISION MADE: 16-FEB-18
Cambridge GB CB4 0WS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit
Siemens Medical Solutions USA, Inc510(k) NO: K173592(Traditional)
ATTN: Cordell L. Fields PHONE NO : 610 4486469
40 Liberty Boulevard Mailcode 65-1SE DECISION MADE: 13-FEB-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
STERIS Corporation 510(k) NO: K173626(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 21-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELERITY 20 Steam Process Challenge Device for Gravity Cycles
STERIS Corporation 510(k) NO: K173629(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5976 Heisley Rd SE DECISION MADE: 21-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
Steris Corporation 510(k) NO: K173633(Traditional)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 28-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELERITY 20 Steam Biological Indicator
STERIS Corporation 510(k) NO: K173634(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5976 Heisley Rd SE DECISION MADE: 12-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Velocity
Varian Medical Systems, Inc. 510(k) NO: K173636(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 15-FEB-18
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trilor Disks, Blocks and Arches
Bioloren S.R.L. 510(k) NO: K173643(Special)
ATTN: Ratti Umberto PHONE NO : 39 02 96703261
via Alessandro Volta 59 SE DECISION MADE: 24-FEB-18
Saronno IT 21047 510(k) STATEMENT
DEVICE: Gazelle Polypropylene Suture and Delivery Device
Dura Tap LLC 510(k) NO: K173644(Abbreviated)
ATTN: Ann R. Lee PHONE NO : 215 5864714
208 Upland Way SE DECISION MADE: 15-FEB-18
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
Fresenius Medical Care Renal Thera510(k) NO: K173651(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 Winter Street SE DECISION MADE: 14-FEB-18
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELERITY 20 Steam Incubator
STERIS Corporation 510(k) NO: K173670(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5976 Heisley Road SE DECISION MADE: 12-FEB-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter
Inari Medical 510(k) NO: K173672(Special)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 05-FEB-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode VLaze
InMode MD Ltd. 510(k) NO: K173677(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 23-FEB-18
Yokneam IL 2066509 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Cap
Cosmo Far East Technology Limited 510(k) NO: K173678(Traditional)
ATTN: Bob An PHONE NO : 86 755 23210240
Room 1504, Building 1, XingJiJia YSE DECISION MADE: 28-FEB-18
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
DiaSorin Inc. 510(k) NO: K173683(Traditional)
ATTN: John C Walter PHONE NO : 651 4399710
1951 Northwestern Ave. SE DECISION MADE: 27-FEB-18
Stillwater MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ophthalmic Software Platform RX
Canon Inc. -Medical Equipment Grou510(k) NO: K173689(Traditional)
ATTN: Shinji Mori PHONE NO : 81 3 37582111
9-1, Imaikami-cho, SE DECISION MADE: 23-FEB-18
Nakahara-ku, Kawasaki JP 211-8501510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
Quidel Corporation 510(k) NO: K173691(Traditional)
ATTN: Jennifer S. Rial PHONE NO : 858 5527910
12544 High Bluff Drive, Suite 200 SE DECISION MADE: 28-FEB-18
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orbitum Bone Staple Implant, X and VI
Orthovestments, LLC 510(k) NO: K173693(Traditional)
ATTN: Robert Weinstein PHONE NO : 404 4357315
1640 Powers Ferry Bldg 9 SE DECISION MADE: 23-FEB-18
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P200TE
Optos plc 510(k) NO: K173707(Traditional)
ATTN: Geoff Fatzinger PHONE NO : 44 0 7741312633
Queensferry House, Carnegie BusineSE DECISION MADE: 28-FEB-18
Dunfermline GB KY118GR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MotoBAND CP Implant System
CrossRoads Extremity Systems, LLC 510(k) NO: K173710(Special)
ATTN: Chad Hollis PHONE NO : 901 2218406
6055 Primacy Pkwy Suite 140 SE DECISION MADE: 12-FEB-18
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVIAN RED
PhotonMD, Inc 510(k) NO: K173729(Traditional)
ATTN: William A Knape PHONE NO : 919 7572033
627 Davis Drive, Suite 400 SE DECISION MADE: 28-FEB-18
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrackX
TrackX Technology, LLC 510(k) NO: K173736(Traditional)
ATTN: Calley Herzog PHONE NO : 720 8833633
5102 Durham Chapel Hill Blvd. SuitSE DECISION MADE: 28-FEB-18
Durham NC 27707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA ARIETTA 850
Hitachi Healthcare Americas Corpor510(k) NO: K173739(Traditional)
ATTN: Doug Thistlethwaite PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 28-FEB-18
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Activmotion Range
Newclip Technics 510(k) NO: K173746(Traditional)
ATTN: Gaelle LUSSORI PHONE NO : 33 2 28213712
Pa de la Lande Sanit Martin 45 rueSE DECISION MADE: 27-FEB-18
Haute-Goulaine FR 44115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prelude IDeal Hydrophilic Sheath Introducer
Merit Medical Systems, Inc. 510(k) NO: K173750(Special)
ATTN: David Thomas PHONE NO : 801 3164956
1600 West Merit Parkway SE DECISION MADE: 15-FEB-18
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iovera system
Myoscience, Inc 510(k) NO: K173763(Traditional)
ATTN: Kent Jones PHONE NO : 510 9331500
46400 Fremont Blvd SE DECISION MADE: 28-FEB-18
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leksell GammaPlan
Elekta Instrument AB 510(k) NO: K173791(Traditional)
ATTN: Matilda Forsberg PHONE NO : 011 468 58725400
Kungstensgatan 18 SE DECISION MADE: 09-FEB-18
Stockholm SE 10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
Camber Spine Technologies 510(k) NO: K173800(Traditional)
ATTN: Michael Black PHONE NO : 855 8999869
418 E. Lancaster Avenue SE DECISION MADE: 02-FEB-18
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
Marvao Medical Devices, Ltd. 510(k) NO: K173805(Traditional)
ATTN: Christopher Davey PHONE NO : 353 0 91759301
GMIT Innovation in Business CentreSE DECISION MADE: 08-FEB-18
Galway IE H91 DCH9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
Liofilchem s. r. l. 510(k) NO: K173817(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 28-FEB-18
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System
Summit Industries LLC 510(k) NO: K173823(Traditional)
ATTN: Tom Boon PHONE NO : 773 3534024
2901 W Lawrence Ave SE DECISION MADE: 09-FEB-18
Chicago IL 60625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THP Hip Fracture Plating System
Biomet, Inc. 510(k) NO: K173826(Traditional)
ATTN: Annette Minthorn PHONE NO : 574 3724294
56 East Bell Drive SE DECISION MADE: 07-FEB-18
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triathlon Total Knee System
Stryker Orthopaedics 510(k) NO: K173849(Traditional)
ATTN: Margaret Crowe Klippel PHONE NO : 201 8315559
325 Corporate Drive SE DECISION MADE: 02-FEB-18
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ez3D-i /E3
Ewoo Soft Co., Ltd. 510(k) NO: K173863(Special)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., SamsSE DECISION MADE: 23-FEB-18
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOWA Neutral Electrodes
BOWA-electronics GmbH & Co. KG 510(k) NO: K173877(Traditional)
ATTN: Wolf-Ruediger Fritz PHONE NO : 49 7072 6002839
Heinrich-Hertz-Strasse. 4-10 SE DECISION MADE: 15-FEB-18
Gomaringen DE 72810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Mariner Pedicle Screw System
SeaSpine Orthopedics Corporation 510(k) NO: K173882(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 06-FEB-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jade PTA Balloon Dilatation Catheter
OrbusNeich Medical Trading Inc. 510(k) NO: K173894(Traditional)
ATTN: John Pazienza PHONE NO : 954 7300711
5363 NW 35th Avenue SE DECISION MADE: 09-FEB-18
Fort Lauderdale FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRX-Revolution Nano Mobile X-ray System
Carestream Health, Inc. 510(k) NO: K173924(Traditional)
ATTN: Victoria A. Wheeler PHONE NO : 585 6278706
150 Verona Street SE DECISION MADE: 05-FEB-18
Rochester NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K173957(Third Party - Traditional)
ATTN: Sulgue Choi PHONE NO : 452 2819898
22010 South East 51st Street SE DECISION MADE: 01-FEB-18
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DRI Benzodiazepine Assay
Microgenics Corporation 510(k) NO: K173963(Traditional)
ATTN: Minoti Patel PHONE NO : 510 9795000
46500 Kato Road SE DECISION MADE: 21-FEB-18
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Remedy Acetabular Cup
Osteoremedies LLC 510(k) NO: K173967(Traditional)
ATTN: Chris Hughes PHONE NO : 901 4533141
6800 Poplar Avenue Suite 120 SE DECISION MADE: 22-FEB-18
Memphis TN 38138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K173981(Third Party - Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
685 East Middlefield Road SE DECISION MADE: 02-FEB-18
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
Menicon Co., Ltd. 510(k) NO: K180004(Traditional)
ATTN: Kenichi Tanaka PHONE NO : 81 52 9351676
21-19, Aoi 3, Naka-ku SE DECISION MADE: 22-FEB-18
Nagoya JP 460-0006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMAXEL CO2 Surgical Laser System
IDS, LTD. 510(k) NO: K180036(Special)
ATTN: Kwang Yeong Ahn PHONE NO : 82 2 2025 1150
105, Byoksan Digital Valley 3 cha,SE DECISION MADE: 02-FEB-18
Seoul KR 08381 510(k) STATEMENT
DEVICE: ACUSON Juniper Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K180039(Third Party - Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
685 East Middlefield Road SE DECISION MADE: 01-FEB-18
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACUSON X800 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K180067(Third Party - Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
685 East Middlefield Road SE DECISION MADE: 07-FEB-18
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SpeediCath Flex Coude Pro
Coloplast 510(k) NO: K180070(Special)
ATTN: Troy Thome PHONE NO : 612 7049909
1601 West River Road North SE DECISION MADE: 02-FEB-18
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: geko T-2 and geko Plus R-2
Firstkind Ltd 510(k) NO: K180082(Traditional)
ATTN: Neil Buckley PHONE NO : 44 845 2222921
Hawk House, Peregrine Business ParSE DECISION MADE: 11-FEB-18
High Wycombe GB hp137dl 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasound System SONIMAGE MX1
Konica Minolta, Inc. 510(k) NO: K180084(Traditional)
ATTN: Tsutomu Fukui PHONE NO : 81 42 5898429
1 Sakura-machi SE DECISION MADE: 08-FEB-18
Hino-shi JP 191-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNiD Spine Analyzer
Medicrea International 510(k) NO: K180091(Special)
ATTN: David Ryan PHONE NO : 00 33 472018787
5389 Route de Strasbourg- Vancia SE DECISION MADE: 08-FEB-18
Rillieux La Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Sky Bio Aligner
Blue Sky Bio LLC 510(k) NO: K180107(Third Party - Traditional)
ATTN: Albert Zickmann PHONE NO : 718 3760422
888 E Belvidere Rd Suite 212 SE DECISION MADE: 09-FEB-18
Grayslake IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Arthrex NanoSuture Anchor
Arthrex Inc. 510(k) NO: K180118(Special)
ATTN: Rebecca R. Homan PHONE NO : 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 12-FEB-18
Naples FL 34108-5553 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Breast BI 7 MR Coil 1.5T Mammavention
Noras MRI products GmbH 510(k) NO: K180123(Traditional)
ATTN: Jens Heidenmann PHONE NO : 49 931 2992717
Leibnizstrasse 4 SE DECISION MADE: 16-FEB-18
Hoechberg DE 97204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Warrior 14 guidewire
Vascular Solutions, Inc 510(k) NO: K180128(Third Party - Traditional)
ATTN: Becky Astrup PHONE NO : 763 7622601
6464 Sycamore Court North SE DECISION MADE: 16-FEB-18
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ELEOS™ Bipolar Acetabular System
Onkos Surgical, Inc. 510(k) NO: K180130(Traditional)
ATTN: Jan Triani PHONE NO : 973 2645400
77 East Halsey Road SE DECISION MADE: 23-FEB-18
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
AtriCure, Inc. 510(k) NO: K180137(Special)
ATTN: Melissa Smallwood PHONE NO : 513 6444736
7555 Innovation Way SE DECISION MADE: 15-FEB-18
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AtriCure cryoICE cryo-ablation probe (CRYO2)
AtriCure, Inc. 510(k) NO: K180138(Special)
ATTN: Melissa Smallwood PHONE NO : 513 6444736
7555 Innovation Way SE DECISION MADE: 15-FEB-18
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIWay Endonasal Access Guide
SPIWay, LLC 510(k) NO: K180141(Special)
ATTN: Eugene Chen PHONE NO : 844 5651226
3600 Corte Castillo SE DECISION MADE: 16-FEB-18
Carlsbad CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Laser fibers
Quanta System SPA 510(k) NO: K180158(Special)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
via acquedotto 109 SE DECISION MADE: 14-FEB-18
Samarate (Va) IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine NewPort Spinal System
SeaSpine Orthopedics Corporation 510(k) NO: K180176(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 20-FEB-18
Carlsbad CA 90228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Natus Quantum
Natus Medical Incorporated DBA Exc510(k) NO: K180181(Special)
ATTN: Sanjay Mehta PHONE NO : 905 2875055
2568 Bristol Circle SE DECISION MADE: 22-FEB-18
Oakville CA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
El.En Electronic Engineering S.p.A510(k) NO: K180193(Special)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 21-FEB-18
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rezum System
NxThera, Inc. 510(k) NO: K180237(Special)
ATTN: Kathy Simpson PHONE NO : 763 5150404
7351 Kirkwood Land North, Suite 13SE DECISION MADE: 27-FEB-18
Maple Grove MN 55331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HeRO Symphony, HeRO ES, HeRO solo/duet
Medical Predictive Science Corpora510(k) NO: K180242(Special)
ATTN: Will King PHONE NO : 434 2200714 113
2246 Ivy Rd Suite 17 SE DECISION MADE: 28-FEB-18
Charlottesville VA 22903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnsoETM
Advanced Cooling Therapy, Inc. d/b510(k) NO: K180244(Special)
ATTN: Erik Kulstad PHONE NO : 708 6510736
3440 S. Dearborn St. #215-South SE DECISION MADE: 28-FEB-18
Chicago IL 60616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Hangzhou Clongene Biotech Co.,Ltd.510(k) NO: K180255(Traditional)
ATTN: Zheng Shujian PHONE NO : 86 571 88262120
Building 4, No.20 Longquan Road, YSE DECISION MADE: 28-FEB-18
Hangzhou CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuickVue Influenza A+B
Quidel Corporation 510(k) NO: K180288(Special)
ATTN: Jennifer S. Rial PHONE NO : 858 5527910
10165 McKellar Court SE DECISION MADE: 13-FEB-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker iVAS 13g Bone Biopsy Kit
Stryker Corporation 510(k) NO: K180327(Special)
ATTN: Kristi Ashton PHONE NO : 269 3895929
4100 E. Milham Avenue SE DECISION MADE: 26-FEB-18
Kalamazoo MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 242
TOTAL WITH SUMMARIES 230
TOTAL WITH STATEMENTS 12
