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  1. Device Approvals, Denials and Clearances

February 2018 510(k) Clearances

February 2018 510(k) Clearances

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