510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2018
DEVICE: IMACTIS CT-Navigation system
IMACTIS, SAS 510(k) NO: K162314(Traditional)
ATTN: MADY BATAILH PHONE NO : 33 476 549540
5 AVENUE DU GRAND SABLON SE DECISION MADE: 24-APR-18
LA TRONCHE FR 38700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nano Varnish, Plaquit, Lightpaint on Surface
DREVE DENTAMID GMBH 510(k) NO: K162408(Traditional)
ATTN: REINER ALTMANN PHONE NO : 49 230 3880714
MAX-PLANCK-STRASSE 31 SE DECISION MADE: 05-APR-18
UNNA DE 59423 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Best Instruminal Applicator
BEST MEDICAL INTERNATIONAL, INC. 510(k) NO: K162499(Traditional)
ATTN: MANNY SUBRAMANIAN PHONE NO : 703 4512378
7643 FULLERTON ROAD SE DECISION MADE: 13-APR-18
SPRINGFIELD VA 22153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oniko nail brace
BEGUM SAGLIK HIZMETLERI TIBBI MALZ510(k) NO: K162525(Traditional)
ATTN: FATMA GULRU ERDOGAN PHONE NO : 905 32 2969648
RESIT GALIP CAD. NO: 124/10 GOP SE DECISION MADE: 25-APR-18
CANKAYA TR 06700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Summit Hip System
DePuy Orthopaedics, Inc. 510(k) NO: K170339(Traditional)
ATTN: Carol S. Ming PHONE NO : 508 9776448
700 Orthopaedic Drive SE DECISION MADE: 26-APR-18
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
i-SENS, Inc. 510(k) NO: K170463(Traditional)
ATTN: Joon Ho Jung PHONE NO : 82 291 66191
43,Banpo-daero 28-gil Seocho-gu SE DECISION MADE: 13-APR-18
Seoul KR 06646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung
Varian Medical Systems Inc 510(k) NO: K170570(Traditional)
ATTN: Lisa Levine PHONE NO : 206 7744226
3100 Hansen Way SE DECISION MADE: 06-APR-18
Palo Alto CA 94304-1038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSonic B|UBM
Lightmed USA, Inc. 510(k) NO: K170761(Traditional)
ATTN: Katrina Hsu PHONE NO : 949 2189555
1130 Calle Cordillera SE DECISION MADE: 13-APR-18
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DTI-1 SLA IMPLANT SYSTEM
DTI Implant Sistemleri Sanayi Tica510(k) NO: K170776(Traditional)
ATTN: Fatih Ormeci PHONE NO : 90 533 1655480
D1-2 No 5 Merkez Mahallesi SE DECISION MADE: 10-APR-18
Cekmekoy TR 34782 510(k) STATEMENT
DEVICE: ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
BioSystems S.A. 510(k) NO: K170901(Traditional)
ATTN: Teresa Maria Cortes PHONE NO : 34 93 3110000 3404
Costa Brava, 30. SE DECISION MADE: 13-APR-18
Barcelona ES e08030 510(k) STATEMENT
DEVICE: ACRON™ TLIF System
SpineMED Ges.m.b.H 510(k) NO: K171151(Traditional)
ATTN: Andreas Bernegger PHONE NO : 43 147 99281
Twarochgasse 11 SE DECISION MADE: 27-APR-18
Wien AT A-1170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Piezosurgery White
Mectron S.p.a 510(k) NO: K171326(Traditional)
ATTN: Franco Zunino PHONE NO : 39 018 535361
via loreto 15 SE DECISION MADE: 13-APR-18
Carasco IT 16042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Automatic Wrist Blood Pressure Monitor MD4300
Grandway Technology (Shenzhen) Lim510(k) NO: K171379(Traditional)
ATTN: Patrick Chow PHONE NO : 852 28516789
Block 7, Zhu Keng Industrial Zone,SE DECISION MADE: 10-APR-18
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OT EQUATOR
Rhein'83 SRL 510(k) NO: K171409(Traditional)
ATTN: Claudia Nardi PHONE NO : 39 05 1244510
Via E.Zago, 10/abc SE DECISION MADE: 09-APR-18
Bologna IT 40128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Etherea MX
Vydence Medical Industria E Comerc510(k) NO: K171443(Traditional)
ATTN: Kathy Maynor PHONE NO : 352 5863113
Rua Aldo Germano Klein, 359 Cep: 1SE DECISION MADE: 20-APR-18
Ceat - Sao Carlos/Sp Sao Paulo BR510(k) STATEMENT
DEVICE: Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
Dreve Dentamid GmbH 510(k) NO: K171562(Abbreviated)
ATTN: Reiner Altmann PHONE NO : 49 230 3880714
Max-Planck-StraBe 31 SE DECISION MADE: 13-APR-18
Unna DE 59423 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
Cook Incorporated 510(k) NO: K171603(Traditional)
ATTN: Erum B. Nasir PHONE NO : 812 3353575 102607
750 Daniels Way SE DECISION MADE: 16-APR-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
Vyaire Medical, Inc. 510(k) NO: K171678(Traditional)
ATTN: Leo Sohlberg PHONE NO : 358 108 508130
Kuortaneenkatu 2 SE DECISION MADE: 30-APR-18
Helsinki FI FIN-00510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instrument basket, for EndoEYE
Olympus Winter & Ibe GmbH 510(k) NO: K171692(Traditional)
ATTN: Jan-Oliver Upmeier PHONE NO : 49 40 669662098
Kuehnstr. 61 SE DECISION MADE: 02-APR-18
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Instrument Kits
JJGC Industria e Comercio de Mater510(k) NO: K171713(Traditional)
ATTN: Julianne de Oliveira CapuchoPHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 05-APR-18
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: encevis
AIT Austrian Institute of Technolo510(k) NO: K171720(Traditional)
ATTN: Tilmann Kluge PHONE NO : 43 50550 4203
Donau-City-Strabe 1 SE DECISION MADE: 19-APR-18
Vienna AT 1220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2 Face / Face Evolution
Heat In A Click 510(k) NO: K171821(Traditional)
ATTN: Guy Levi PHONE NO : 1 954 5189777
1975 Tigertail Blvd Dania SE DECISION MADE: 26-APR-18
Homestead FL 33034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corin Optimized Positioning System (OPS™) Plan
Corin USA Limited 510(k) NO: K171847(Traditional)
ATTN: Kathy Trier PHONE NO : 813 7662112
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 05-APR-18
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P50 Series Dental Operative Unit and Accessories
Pelton & Crane 510(k) NO: K171872(Traditional)
ATTN: Frank Ray PHONE NO : 704 5877227
11727 Fruehauf Drive SE DECISION MADE: 26-APR-18
Charlotte NC 28273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sysmex UF-5000 Fully Automated Urine Particle Analyzer
Sysmex America, Inc. 510(k) NO: K171883(Traditional)
ATTN: Sharita Brooks PHONE NO : 224 5439618
577 Aptakisic Road SE DECISION MADE: 23-APR-18
Lincolnshire IL 60069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Frova Intubating Introducer
Cook Incorporated 510(k) NO: K171917(Traditional)
ATTN: Kotei Aoki PHONE NO : 812 3353575 102630
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 23-APR-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wedge Microcatheter
Micro Vention, Inc. 510(k) NO: K172014(Traditional)
ATTN: Chet Jones PHONE NO : 714 2478055
1311 Valencia Avenue SE DECISION MADE: 05-APR-18
Tustin CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Riva Star
SDI Limited 510(k) NO: K172047(Traditional)
ATTN: Ray Cahill PHONE NO : 61 3 87277111
3-13 Brunsdon Street SE DECISION MADE: 11-APR-18
Bayswater AU 3153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Shanghai Berry Electronic Tech Co.510(k) NO: K172141(Traditional)
ATTN: Xuezhi Yin PHONE NO : 86 21 58531958
Unit C, 1st Floor, 7th Building, NSE DECISION MADE: 04-APR-18
Shanghai CN 201112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMI 780 PET/CT System
Shanghai United Imaging Healthcare510(k) NO: K172143(Traditional)
ATTN: Shumei Wang PHONE NO : 86 21 67076888 6776
No.2258 Chengbei Road,Jiading DistSE DECISION MADE: 13-APR-18
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hysteroscopy System
Chongquin Jinshan Science & Techno510(k) NO: K172151(Traditional)
ATTN: Qing Xu PHONE NO : 023 86098111
Yubei District No. 18 Ningshang AvSE DECISION MADE: 09-APR-18
Chongqing CN 400000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Isolette 8000 plus
Draeger Medical Sytems, Inc. 510(k) NO: K172154(Traditional)
ATTN: Gale Winarsky PHONE NO : 215 6602239
3135 Quarry Road SE DECISION MADE: 19-APR-18
Telford PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
StatGuard, LLC 510(k) NO: K172155(Traditional)
ATTN: Gary Mills PHONE NO : 503 5674059
7555 Cason Lane SE DECISION MADE: 12-APR-18
Gladstone OR 97027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical EPK-3000 Video Imaging System
Pentax Medical 510(k) NO: K172156(Traditional)
ATTN: William Goeller PHONE NO : 800 4315880 2318
3 Paragon Drive SE DECISION MADE: 05-APR-18
Montvale NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPIC Navigated Instruments
Astura Medical 510(k) NO: K172166(Traditional)
ATTN: Troy Taylor PHONE NO : 760 8148047
3186 Lionshead Avenue Suite 100 SE DECISION MADE: 27-APR-18
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zenith Flex System
InNeuroCo, Inc. 510(k) NO: K172167(Traditional)
ATTN: Marc Litzenberg PHONE NO : 954 4725988
4635 NW 103rd Avenue SE DECISION MADE: 19-APR-18
Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiaSpect Tm, DiaSpect Tm Cuvettes
EKF-diagnostic GmbH 510(k) NO: K172173(Traditional)
ATTN: Mick Fenton PHONE NO : 49 392 035110
Ebendorfer Chaussee 3 SE DECISION MADE: 06-APR-18
Barleben DE 39179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inno-Hydrowire
Suzhou Innomed Medical Device Co.,510(k) NO: K172187(Traditional)
ATTN: Jimmy Li PHONE NO : 86 188 62238195
218 Xinghu St., #B1-404 SE DECISION MADE: 11-APR-18
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica IM Folate Assay
Siemens Healthcare Diagnostics Inc510(k) NO: K172201(Traditional)
ATTN: Darius Daruwala PHONE NO : 914 5242812
511 Benedict Avenue SE DECISION MADE: 12-APR-18
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAJA™ Ligament Correction System
Cousin Biotech S.A.S. 510(k) NO: K172206(Traditional)
ATTN: Mathilde Collet PHONE NO : 011 333 20144130
8 Rue De L'abbe Bonpain SE DECISION MADE: 10-APR-18
Wervicq-Sud FR 59117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLANT 18
Dentsply Sirona 510(k) NO: K172239(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street SuiteSE DECISION MADE: 04-APR-18
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
Euroimmun US, Inc. 510(k) NO: K172244(Traditional)
ATTN: Daniel Castellanos PHONE NO : 973 6561000 104
1 Bloomfield Avenue SE DECISION MADE: 20-APR-18
Mountain Lakes NJ 07046 510(k) STATEMENT
DEVICE: EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
Euroimmun US, Inc. 510(k) NO: K172252(Traditional)
ATTN: Daniel Castellanos PHONE NO : 973 6561000 104
1 Bloomfield Avenue SE DECISION MADE: 20-APR-18
Mountain Lakes NJ 07046 510(k) STATEMENT
DEVICE: Novasight Hybrid System
Conavi Medical Inc. 510(k) NO: K172258(Traditional)
ATTN: Sam Mostafavi PHONE NO : 416 4830100
293 Lesmill Road SE DECISION MADE: 27-APR-18
Toronto CA M3B2V1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fusion OMNI Sphincterotome
Wilson-Cook Medical, Inc./ Cook En510(k) NO: K172288(Traditional)
ATTN: Sierra Lowe PHONE NO : 336 7440154 396506
4900 Bethania Station Road SE DECISION MADE: 17-APR-18
Winston Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SuperSlyde Personal Lubricant
ICM Pharma Pte Ltd 510(k) NO: K172306(Traditional)
ATTN: Dennis Fortich PHONE NO : 65 62 965411
26 Kallang Place #05-17 SE DECISION MADE: 19-APR-18
Singapore SG 339157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rotarex S Catheter Set – 6F x 110 cm, Rotarex S Catheter Set – 6F x 135 cm, Rotarex S Catheter Set – 8F x 85 cm, Rotarex S Catheter Set – 8F x 110 cm, Drive System, Replacement Control Unit (with cord), Replacement Motor (with cord), Replacement Footswitch, Replacement Power Cord, Replacement 0.018” Guidewire 220 cm with 4 cm angled tip, Replacement 0.018” Guidewire 270 cm with 4 cm angled tip, Replacement 0.018” Guidewire 320 cm with 4 cm angled tip, Replacement 0.018” Guidewire 220 cm with 4 cm angled tip (5 pack), Replacement 0.018” Guidewire/270 cm with 4 cm angled tip (5 pack), Replacement 0.018” Guidewire 320 cm with 4 cm angled tip (5 pack), Replacement Collecting Bag, 2000 ml, Replacement Sterile drape for motor or footswitch
Straub Medical AG 510(k) NO: K172315(Traditional)
ATTN: Amy Ehlenfeldt PHONE NO : 41 81 7200460
Straubstrasse 12 SE DECISION MADE: 12-APR-18
Wangs CH ch 7323 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Status Engine
Isansys Lifecare Ltd 510(k) NO: K172329(Traditional)
ATTN: Julian Jones PHONE NO : 44 1235 436225
8C Park Square Milton Park, AbingdSE DECISION MADE: 23-APR-18
Oxford GB OX14 4RR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panoramic Oxygen Mask (POM)
Pom Medical, LLC 510(k) NO: K172365(Traditional)
ATTN: Jeff Voss PHONE NO : 855 7660202
1230 Madera Rd., Suite 5, Box 101 SE DECISION MADE: 19-APR-18
Simi Valley CA 92065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bipolar Micro-Coagulation Forceps
Gunter Bissinger Medizintechnik Gm510(k) NO: K172368(Traditional)
ATTN: Matthias Bissinger PHONE NO : 49 7641 914330
Hans-Theisen-Str. 1 SE DECISION MADE: 05-APR-18
Teningen DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC Fuji Direct
GC America Inc. 510(k) NO: K172382(Traditional)
ATTN: Mark Heiss PHONE NO : 708 5970900
3737 W. 127th Street SE DECISION MADE: 02-APR-18
Alsip IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advisor HD Grid Mapping Catheter, Sensor Enabled
St. Jude Medical, Inc. 510(k) NO: K172393(Traditional)
ATTN: Jennifer Ruether PHONE NO : 651 7565400
5050 Nathan Lane N SE DECISION MADE: 23-APR-18
Plymouth MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite Velocity Cardiac Mapping System v5.2
St. Jude Medical 510(k) NO: K172396(Traditional)
ATTN: Melissa Frank PHONE NO : 1 651 7562954
One St. Jude Medical Drive SE DECISION MADE: 23-APR-18
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synermed Opiate Enzyme Immunoassay
Infrared Laboratory Systems, LLC (510(k) NO: K172416(Traditional)
ATTN: Julie Paschal PHONE NO : 317 8961565
17408 Tiller Court, Suite 1900 SE DECISION MADE: 19-APR-18
Westfield IN 40674 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AViTA Radar Thermo NT16 Series IR Thermometer
Avita Corporation 510(k) NO: K172427(Traditional)
ATTN: Steven Jhou PHONE NO : 886 2 85121568
9F, No.78, Sec. 1, Kwang-Fu Road.,SE DECISION MADE: 19-APR-18
New Taipei City TW 24158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADHEAR System
MED-EL Elektromedizinische Geraete510(k) NO: K172460(Traditional)
ATTN: Elizabeth Gfoeller PHONE NO : 43 577 885614
Fuerstenweg 77a SE DECISION MADE: 27-APR-18
Innsbruck AT 6020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XD880A Ultrasonic Osteotomy Surgical System
Morley Research Consortium 510(k) NO: K172464(Traditional)
ATTN: Suzan Davis PHONE NO : 1 508 2715016
Four Concourse Parkway Suite 215 SE DECISION MADE: 24-APR-18
Atlanta GA 30328 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSchemaView RAPID
iSchemaView, Inc. 510(k) NO: K172477(Traditional)
ATTN: Jim Rosa PHONE NO : 650 3889767
201 Marshall Street, Ste. 101 SE DECISION MADE: 19-APR-18
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS device-EmeTerm, CinvStop
WAT Medical Technology (Ningbo) Co510(k) NO: K172478(Traditional)
ATTN: Rodney Zhang PHONE NO : 86 574 65060811
Room703-711, No.2 North Taoyuan RoSE DECISION MADE: 19-APR-18
Ningbo CN 315600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reform® POCT System
Precision Spine, Inc. 510(k) NO: K172495(Traditional)
ATTN: Michael C. Dawson PHONE NO : 601 4204244
2050 Executive Drive SE DECISION MADE: 11-APR-18
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hickman TriFusion Catheter
C.R. Bard, Inc 510(k) NO: K172511(Traditional)
ATTN: Mona Shahrebani PHONE NO : 801 5225967
605 North 5600 West SE DECISION MADE: 20-APR-18
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Balloon Catheter and Balloon Ureteral Dilator Set
Cook Incorporated 510(k) NO: K172588(Traditional)
ATTN: Carly Powell PHONE NO : 812 3392235 104913
750 Daniels Way SE DECISION MADE: 19-APR-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
ITW Contamination Control Electron510(k) NO: K172598(Traditional)
ATTN: Steve Cook PHONE NO : 770 4244888
8125 Cobb Center Drive SE DECISION MADE: 19-APR-18
Kennesaw GA 30152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
Olympus Medical Systems Corp. 510(k) NO: K172610(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 17-APR-18
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kisses Plus Implant System
ACHIMHAI Medical Corporation 510(k) NO: K172630(Traditional)
ATTN: Ji Ho Jung PHONE NO : 82 70 42964318
28, Namyang-ro, 930beon-gil, NamyaSE DECISION MADE: 03-APR-18
Hwaseong-si KR 18255 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY Total Ankle System
Wright Medical Technology, Inc. 510(k) NO: K172633(Traditional)
ATTN: Tara Conrad PHONE NO : 901 8674367
1023 Cherry Road SE DECISION MADE: 26-APR-18
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: High-Flo Silver Polyethylene Catheter
Cook Incorporated 510(k) NO: K172635(Traditional)
ATTN: Jessica Swafford PHONE NO : 812 3353575 104260
750 Daniels Way SE DECISION MADE: 03-APR-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitaMESH Macroporous PP Surgical Mesh
Proxy Biomedical Ltd. 510(k) NO: K172636(Traditional)
ATTN: Adrienne Tierney PHONE NO : 353 091896934
Coilleach, Spiddal SE DECISION MADE: 30-APR-18
Galway IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agile Nail
Orthofix Srl 510(k) NO: K172699(Traditional)
ATTN: Gianluca Ricadona PHONE NO : 39 045 6719000
Via delle Nazioni 9 SE DECISION MADE: 23-APR-18
Bussolengo IT 37012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACOE silcosoft Tracheostomy Tube
TRACOE medical GmbH 510(k) NO: K172720(Traditional)
ATTN: Eva Schaeffer PHONE NO : 49 61 3691690
Reichelsheimer Str. 1/3 SE DECISION MADE: 27-APR-18
Nieder-Olm DE 55268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
Olympus Medical Systems Corp. 510(k) NO: K172726(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 30-APR-18
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemoclip
Hangzhou AGS MedTech CO., Ltd 510(k) NO: K172727(Traditional)
ATTN: Chunqi Han PHONE NO : 86 571 87671223
Building 6, Kangxin Road No.597 QiSE DECISION MADE: 16-APR-18
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WR19 System
Zeto, Inc. 510(k) NO: K172735(Traditional)
ATTN: Aswin Gunasekar PHONE NO : 512 7892891
2336 Park Ave SE DECISION MADE: 17-APR-18
Santa Clara CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYALURONIC ACID TOPICAL WOUND CREAM
VIRCHOW BIOTECH PVT LTD 510(k) NO: K172747(Traditional)
ATTN: Bruce Gibbins PHONE NO : 001 503 7817565
5903 SE Milwaukie Ave SE DECISION MADE: 27-APR-18
Portland OR 97202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Keymill
Mycone Dental Supply Company, Inc.510(k) NO: K172764(Traditional)
ATTN: Priscilla Herpai PHONE NO : 856 6634700
480 S Democrat Road SE DECISION MADE: 27-APR-18
Gibbstown NJ 08027 510(k) STATEMENT
DEVICE: ZOOM
Zetta Medical Technologies, LLC. 510(k) NO: K172768(Traditional)
ATTN: Main M. Ghazal PHONE NO : 847 5509990
1313 Ensell Road SE DECISION MADE: 24-APR-18
Lake Zurich IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroCap
Memory MD INC 510(k) NO: K172866(Traditional)
ATTN: Abdus-Salaam Muwwakkil PHONE NO : 1 215 3416373
205 E 42nd Street, 14th Floor SE DECISION MADE: 27-APR-18
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Astral 100/150
ResMed Ltd 510(k) NO: K172875(Traditional)
ATTN: Peter Jennings PHONE NO : 61 2 88841000
1 Elizabeth Macarthur Drive SE DECISION MADE: 26-APR-18
Bella Vista AU 2153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property Gm510(k) NO: K172880(Traditional)
ATTN: Gerhard Frick PHONE NO : 41 717 277059
Espenstrasse 139 SE DECISION MADE: 18-APR-18
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K172887(Traditional)
ATTN: Sammy Li PHONE NO : 86 020 66393598
2nd Building, Juntuo Industry ParkSE DECISION MADE: 19-APR-18
Guangzhou CN 511400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EV-804 OTC Pain Relief TENS
Everyway Medical Instruments Co., 510(k) NO: K172919(Traditional)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3Fl., No. 5, Lane 155, Sec. 3, PeiSE DECISION MADE: 19-APR-18
New Taipei City TW 22203 510(k) STATEMENT
DEVICE: Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
Top Glove Sdn. Bhd. 510(k) NO: K172923(Traditional)
ATTN: Noor Akilah Binti Saidin PHONE NO : 03 3392 1992
Lot 4968, Jalan Teratai, Batu 6 OfSE DECISION MADE: 26-APR-18
Klang MY 41050 510(k) STATEMENT
DEVICE: mCare Powder-free Blue Nitrile Examination Gloves
Mercator Medical (Thailand) LTD. 510(k) NO: K172930(Traditional)
ATTN: Dariusz Jan Krezymon PHONE NO : 66 74 584222
88/2 Moo 12 Tambon Kampaengphet SE DECISION MADE: 13-APR-18
Amphur Rattaphum TH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALF DOME Posterior Lumbar Interbody System
Astura Medical 510(k) NO: K172947(Special)
ATTN: Thomas Purcell PHONE NO : 760 8148047
3186 Lionshead Ave, Suite 100 SE DECISION MADE: 18-APR-18
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LungVision Tool
Body Vision Medical Ltd. 510(k) NO: K172955(Traditional)
ATTN: Dorian Averbuch PHONE NO : 646 8637848
34 SOKOLOV ST. SE DECISION MADE: 26-APR-18
Ramat Hasharon IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medicant Mucosal Atomizer
Medica Holdings, LLC 510(k) NO: K172956(Traditional)
ATTN: George Reed PHONE NO : 503 2271900
5200 Meadows Rd Ste 150 SE DECISION MADE: 06-APR-18
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Master-Frank N95 Particulate Respirator
Master & Frank Enterprise Co., Ltd510(k) NO: K172963(Traditional)
ATTN: Shuge Zhao PHONE NO : 86 769 83361381
Banhu Industrial District SE DECISION MADE: 04-APR-18
Dong Duan CN 523000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mercury® Spinal System
Spinal Elements Inc. 510(k) NO: K172967(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071816
3115 Melrose Dr., Suite 200 SE DECISION MADE: 10-APR-18
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uWS-MI
Shanghai United Imaging Healthcare510(k) NO: K172998(Traditional)
ATTN: Shumei Wang PHONE NO : 86 021670 768886776
NO.2258 Chengbei Road SE DECISION MADE: 05-APR-18
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Algidex Ag Silver Alginate Wound Dressing
DeRoyal Industries, Inc. 510(k) NO: K173072(Traditional)
ATTN: Sarah Bennett PHONE NO : 865 3626112
200 DeBusk Lane SE DECISION MADE: 04-APR-18
Powell TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor
Stryker 510(k) NO: K173074(Special)
ATTN: Jacob Scheenstra PHONE NO : 303 3577618
5670 Greenwood Plaza Blvd. Suite 2SE DECISION MADE: 04-APR-18
Greenwood Village CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
Philips Medical Systems Nederland 510(k) NO: K173079(Abbreviated)
ATTN: Jan van de Kerkhot PHONE NO : 31 613 3011542
Veenpluis 4-6 SE DECISION MADE: 04-APR-18
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pivet and Soft-Pass Embryo Transfer Catheter Sets
Cook Incorporated 510(k) NO: K173103(Traditional)
ATTN: Naomi Funkhouser PHONE NO : 812 3353575 104371
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 13-APR-18
Bloomington IN 47402-0489 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phasix ST Mesh
C. R. Bard Inc 510(k) NO: K173143(Traditional)
ATTN: Tony John PHONE NO : 401 8258692
100 Crossings Boulevard SE DECISION MADE: 25-APR-18
Warwick RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNITY Sacroiliac Joint Fixation System
Huvexel Co., Ltd 510(k) NO: K173201(Traditional)
ATTN: Sung Hee-Lee PHONE NO : 82 31 7763690
101-105 Megacenter, SK Technopark,SE DECISION MADE: 26-APR-18
Seongnam-si KR 124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIC invent Dental Implant Systems
SIC invent AG 510(k) NO: K173207(Abbreviated)
ATTN: Cretia Arlene McNett PHONE NO : 41 061 2613966
Birmannsgasse 3 SE DECISION MADE: 05-APR-18
Basel CH ch-4055 510(k) STATEMENT
DEVICE: CardiMax Electrocardiograph
Fukuda Denshi USA, Inc. 510(k) NO: K173226(Traditional)
ATTN: Doug Blakely PHONE NO : 210 2404521
17725-C NE 65th St. SE DECISION MADE: 16-APR-18
Redmond WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
Pt. Medisafe Technologies 510(k) NO: K173258(Traditional)
ATTN: Deepak Bang PHONE NO : 62 61 30007134
J1 Batang Kuis, Gg Tambak Rejo PasSE DECISION MADE: 20-APR-18
Medan ID 20362 510(k) STATEMENT
DEVICE: Finessis Intense Polyisoprene Surgical Glove
Lucenxia Prescience Ag 510(k) NO: K173304(Special)
ATTN: Robert Hill PHONE NO : 41 417 689126
Rathausstrasse 7 SE DECISION MADE: 30-APR-18
Baar CH 6341 510(k) STATEMENT
DEVICE: DiLumen C2; DiLumen Tool Mount
Lumendi, LLC 510(k) NO: K173317(Traditional)
ATTN: Dennis Daniels PHONE NO : 203 4632669
253 Post Road West SE DECISION MADE: 17-APR-18
Westport CT 06880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle
Teleflex Medical 510(k) NO: K173321(Traditional)
ATTN: Kristen Bisanz PHONE NO : 919 4334932
3015 Carrington Mill Blvd. SE DECISION MADE: 25-APR-18
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE ENFORM Biomaterial
W.L. Gore & Associates, Inc. 510(k) NO: K173333(Traditional)
ATTN: Barbara L Smith PHONE NO : 410 5068189
1505 N. Fourth Street SE DECISION MADE: 05-APR-18
Flagstaff AZ 86004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intuitive Surgical EndoWrist Vessel Sealer Extend
Intuitive Surgical, Inc. 510(k) NO: K173337(Traditional)
ATTN: Crystal Ong PHONE NO : 408 5238636
1266 Kifer Road SE DECISION MADE: 26-APR-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSM Biomedical Calcium Phosphate Cement
Kensey Nash Corporation dba DSM Bi510(k) NO: K173362(Traditional)
ATTN: Susan Pileggi PHONE NO : 484 7132173
735 Pennsylvania Drive SE DECISION MADE: 03-APR-18
Exton PA 19431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VisuMax Femtosecond Laser
Carl Zeiss Meditec, Inc. 510(k) NO: K173371(Traditional)
ATTN: Todd Otani PHONE NO : 925 5574513
5160 Hacienda Drive SE DECISION MADE: 13-APR-18
Dublin CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
Smiths Medical ADS, Inc. 510(k) NO: K173384(Traditional)
ATTN: Donna M. Semlak PHONE NO : 763 3833076
6000 Nathan Lane North SE DECISION MADE: 10-APR-18
Minneapolis MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs
Lucenxia Prescience AG 510(k) NO: K173386(Traditional)
ATTN: Robert Hill PHONE NO : 41 417 689126
Rathausstrasse 7 SE DECISION MADE: 09-APR-18
Baar CH 6341 510(k) STATEMENT
DEVICE: hipEOS
oneFIT Medical 510(k) NO: K173390(Traditional)
ATTN: Camille Vernay PHONE NO : 33 3 81252427
18 Rue Alain Savary SE DECISION MADE: 27-APR-18
Besancon FR 25000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert Xpress Strep A
Cepheid 510(k) NO: K173398(Dual Track)
ATTN: Yi-Ping Lin PHONE NO : 408 4006838
904 Caribbean Drive SE DECISION MADE: 26-APR-18
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENZA-A Titanium ALIF
Camber Spine Technologies 510(k) NO: K173432(Traditional)
ATTN: Damian Heinz PHONE NO : 484 4204286
418 E. Lancaster Ave. SE DECISION MADE: 18-APR-18
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments
Medacta International SA 510(k) NO: K173472(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 19-APR-18
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LigaPASS
Medicrea International S.A. 510(k) NO: K173506(Traditional)
ATTN: David Ryan PHONE NO : 33 4 72018787
5389 route de Strasbourg-Vancia SE DECISION MADE: 03-APR-18
Rillieux-la-Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Admiral Xtreme
Medtronic Vascular 510(k) NO: K173515(Third Party - Traditional)
ATTN: Maddalena Pinsi PHONE NO : 39 06 9068307
3576 Unoacal Place SE DECISION MADE: 12-APR-18
Santa Rosa CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader
3M Company 510(k) NO: K173519(Traditional)
ATTN: Hilary B. Hovde PHONE NO : 651 7360364
3M Center, Building 275-5W-06 SE DECISION MADE: 23-APR-18
St Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovoGro
OsteoNovus, Inc. 510(k) NO: K173525(Traditional)
ATTN: Brian M. Schlossberg PHONE NO : 419 5305940
1510 North Westwood Avenue, Suite SE DECISION MADE: 06-APR-18
Toledo OH 43606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTIO MMG Gen 2
Medos International, SARL 510(k) NO: K173526(Traditional)
ATTN: Karen Sylvia PHONE NO : 508 9773804
Chemin-Blanc 38 SE DECISION MADE: 05-APR-18
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAMP Venous/Arterial Blood Management Protection System
Edwards Lifesciences, LLC 510(k) NO: K173586(Traditional)
ATTN: Ye Seul Kim PHONE NO : 949 2502445
One Edwards Way SE DECISION MADE: 05-APR-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scenium VE20 Software
Siemens Medical Solutions USA, Inc510(k) NO: K173597(Special)
ATTN: Veronica Padharia PHONE NO : 630 8775761
810 Innovation Drive SE DECISION MADE: 04-APR-18
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device
SeaSpine Orthopedics Corporation 510(k) NO: K173606(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 13-APR-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra Coil 400, Ruby Coil System, POD System
Penumbra, Inc. 510(k) NO: K173614(Traditional)
ATTN: Aditi Kolla PHONE NO : 510 9952010
One Penumbra Place SE DECISION MADE: 17-APR-18
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Universal Select Sterilization Tray System
Paragon Medical 510(k) NO: K173615(Third Party - Traditional)
ATTN: Rebecca Walker PHONE NO : 574 5942140 10384
8 Matchett Drive SE DECISION MADE: 18-APR-18
Pierceton IN 46562 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO
Siemens Medical Solutions USA, Inc510(k) NO: K173632(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 4486477
40 Liberty Blvd. SE DECISION MADE: 13-APR-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
Siemens Medical Solutions, Inc 510(k) NO: K173639(Traditional)
ATTN: Denise Adams PHONE NO : 610 4486139
40 Liberty Boulevard 65-1A SE DECISION MADE: 02-APR-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wingman 35 Crossing Catheter
ReFlow Medical, Inc. 510(k) NO: K173661(Traditional)
ATTN: Rebecca K Pine PHONE NO : 760 8095178
1003 Calle Sombra SE DECISION MADE: 18-APR-18
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-D Balance
King-Devick Technologies, Inc. 510(k) NO: K173669(Traditional)
ATTN: Lori Grover PHONE NO : 630 3594383
Two Mid America Plaza Suite 110 SE DECISION MADE: 02-APR-18
Oakbrook Terrace IL 60181 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
Cook Incorporated 510(k) NO: K173686(Traditional)
ATTN: Naomi Funkhouser PHONE NO : 812 3353575 104371
750 Daniels Way P.O. Box 489 SE DECISION MADE: 11-APR-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-Actor 200 Vibration Massage System
Storz Medical AG 510(k) NO: K173692(Traditional)
ATTN: Pavel Novak PHONE NO : 41 0 716774513
Lohstampfestrasse 8 SE DECISION MADE: 13-APR-18
Tägerwilen CH CH-8274 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Pump by Babyation
Babyation, LLC 510(k) NO: K173699(Traditional)
ATTN: Jared Miller PHONE NO : 844 7447867
911 Washington Ave Suite 427 SE DECISION MADE: 04-APR-18
St. Louis MO 63101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AlertWatch:OB
AlertWatch, Inc. 510(k) NO: K173715(Traditional)
ATTN: Justin Adams PHONE NO : 734 9988344
1600 Huron Parkway, Bldg. 520, SteSE DECISION MADE: 23-APR-18
Ann Arbor MI 48109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
Phadia AB 510(k) NO: K173726(Traditional)
ATTN: Ulf Karlberg PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 16-APR-18
Uppsala SE 75137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set
Greiner Bio-One NA Inc 510(k) NO: K173757(Traditional)
ATTN: Manfred Abel PHONE NO : 704 2617823
4238 Capital Drive SE DECISION MADE: 19-APR-18
Monroe NC 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A. L. P. S. Clavicle Plating System
Biomet Inc. 510(k) NO: K173767(Traditional)
ATTN: Dhaval Saraiya PHONE NO : 305 2696386
56 East Bell Drive SE DECISION MADE: 06-APR-18
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clench Compression Staple
F & A Foundation LLC d.b.a. Reign 510(k) NO: K173775(Traditional)
ATTN: Daniel Lanois PHONE NO : 918 3029546
6303 E 102nd Street Suite 200 SE DECISION MADE: 06-APR-18
Tulsa OK 74137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNiD Patient Specific 3D printed cage
Medicrea International S.A. 510(k) NO: K173782(Traditional)
ATTN: David Ryan PHONE NO : 0033 472 018787
5389 route de Strasbourg-Vancia SE DECISION MADE: 25-APR-18
Rillieux-La-Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NM/CT 850, NM/CT 860
GE Healthcare 510(k) NO: K173816(Traditional)
ATTN: George Mashour PHONE NO : 972 4 8563666
4 Hayozma Street SE DECISION MADE: 17-APR-18
Tirat Hacarmel IL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Xi Surgical System, da Vinci X Surgical System
Intuitive Surgical, Inc 510(k) NO: K173842(Traditional)
ATTN: Brandon Hansen PHONE NO : 408 5232100
1266 Kifer Road SE DECISION MADE: 23-APR-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sharpsite AC Rigid Endsocope
Medtronic Xomed Inc. 510(k) NO: K173855(Traditional)
ATTN: Shravan Chawla PHONE NO : 904 2797577
6743 Southpoint Drive North SE DECISION MADE: 20-APR-18
Jacksonville FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALIX ADVANCE Anchor with DYNACORD Suture
Medos International SARL 510(k) NO: K173859(Traditional)
ATTN: Tatyana Tatyana Korsunsky PHONE NO :
Chemin-Blanc 38, Case Postale SE DECISION MADE: 11-APR-18
Le Locle CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
Volcano Corporation 510(k) NO: K173860(Traditional)
ATTN: Nora York PHONE NO : 858 7641286
3721 Valley Centre Dr Ste 500 SE DECISION MADE: 11-APR-18
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: trophon2
Nanosonics Limited 510(k) NO: K173865(Traditional)
ATTN: Ruth Cremin PHONE NO : 612 80 631600
14 Mars Road SE DECISION MADE: 24-APR-18
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axis Anterior Cervical Plate System
Axis Orthopaedics 510(k) NO: K173867(Traditional)
ATTN: Craig Wilcox PHONE NO : 907 2023111
34355 Poppy Wood St. SE DECISION MADE: 05-APR-18
Soldotna AK 99669 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corin TriFit CF Hip Stem
Corin USA Limited 510(k) NO: K173880(Traditional)
ATTN: Rachel King PHONE NO : 813 9774469
12750 Citrus Park Lane SE DECISION MADE: 11-APR-18
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genesys Spine Binary Lumbar Plate System
Genesys Spine 510(k) NO: K173885(Traditional)
ATTN: Brian J. Bergeron PHONE NO : 512 3817071
1250 South Capital of Texas HighwaSE DECISION MADE: 03-APR-18
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Cautery Electrode (PTFE)
Medline Industries, Inc. 510(k) NO: K173889(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
Three Lakes Drive SE DECISION MADE: 09-APR-18
Northfield IL 60093 510(k) STATEMENT
DEVICE: Microcyn Antimicrobial Hydrogel
Sonoma Pharmaceuticals, Inc. 510(k) NO: K173896(Traditional)
ATTN: Brian Martin PHONE NO : 707 5597181
1129 N. McDowell Blvd. SE DECISION MADE: 02-APR-18
Petaluma CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.via MI Workflows
Siemens Medical Solutions USA, Inc510(k) NO: K173897(Special)
ATTN: Veronica Padharia PHONE NO : 630 8775761
810 Innovation Drive SE DECISION MADE: 05-APR-18
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Univers Revers Modular Glenoid System
Arthrex Inc. 510(k) NO: K173900(Traditional)
ATTN: Courtney Smith PHONE NO : 1 239 6435553 71720
1370 Creekside Boulevard SE DECISION MADE: 20-APR-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System – GM Line
JJGC Industria e Comercio de Mater510(k) NO: K173902(Traditional)
ATTN: Julianne de Oliveira CapuchoPHONE NO : 55 41 21691000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 20-APR-18
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reza Band, Reflux Band
Somna Therapeutics, L.L.C. 510(k) NO: K173934(Traditional)
ATTN: James S. Miller PHONE NO : 262 3455553
W175 N11081 StoneWood Dr. SE DECISION MADE: 13-APR-18
Germantown WI 53022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mediant Anterior Cervical Plating System
Intelligent Implant Systems, LLC 510(k) NO: K173935(Traditional)
ATTN: Michael Nutt PHONE NO : 704 4241009
3300 International Airport Dr; STESE DECISION MADE: 16-APR-18
Charlotte NC 28208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
Visco Vision Inc 510(k) NO: K173958(Traditional)
ATTN: Evan Huang PHONE NO : 886 3 3596868
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 03-APR-18
Taoyuan TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viamo c100 TUS-VC100 Diagnostic Ultrasound System
Toshiba Medical Systems Corporatio510(k) NO: K173962(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 20-APR-18
Otawara-Shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OVOMotion Shoulder Arthroplasty System
Arthrosurface, Inc. 510(k) NO: K173964(Traditional)
ATTN: Dawn J. Wilson PHONE NO : 508 5203003
28 Forge Parkway SE DECISION MADE: 18-APR-18
Franklin MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rampart One Lumbar Interbody Fusion Device
Spineology Inc. 510(k) NO: K180002(Traditional)
ATTN: Jacqueline A. Hauge PHONE NO : 651 2568500
7800 3rd Street N., Suite 600 SE DECISION MADE: 25-APR-18
St. Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Creagh Medical, Ltd. 510(k) NO: K180007(Traditional)
ATTN: Shane Costello PHONE NO : 353 90 9646300
IDA Business Park SE DECISION MADE: 19-APR-18
Ballinasloe IE H53 K8P4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
Medtronic, Inc. 510(k) NO: K180030(Traditional)
ATTN: Nancy Cameron PHONE NO : 763 5262355
8200 Coral Sea St. NE SE DECISION MADE: 24-APR-18
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8mm Monopolar Curved Scissors
Intuitive Surgical, Inc 510(k) NO: K180033(Traditional)
ATTN: Gayle Perry PHONE NO : 408 5232100
1266 Kifer Road SE DECISION MADE: 06-APR-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Beacon EUS Access System
Covidien llc 510(k) NO: K180037(Traditional)
ATTN: Rachel Silva PHONE NO : 408 3287359
15 Hampshire Street SE DECISION MADE: 26-APR-18
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDR MRI Lumen Marker
C4 Imaging LLC 510(k) NO: K180069(Traditional)
ATTN: Andrew Bright PHONE NO : 609 9335895
196 West Ashland Street SE DECISION MADE: 27-APR-18
Doylestown PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
Innovasis, Inc. 510(k) NO: K180078(Traditional)
ATTN: Marshall McCarty PHONE NO : 801 2612236
614 East 3900 South SE DECISION MADE: 17-APR-18
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBERGRAFT BG Matrix Bone Graft Substitute
Prosidyan, Inc 510(k) NO: K180080(Traditional)
ATTN: Charanpreet S Bagga PHONE NO : 908 5173666
30 Technology Drive SE DECISION MADE: 06-APR-18
Warren NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAILWAY Sheathless Access System
Cordis Corporation 510(k) NO: K180081(Traditional)
ATTN: Michelle Ragozzino Rodgers PHONE NO : 408 2733444
1820 McCarthy Boulevard SE DECISION MADE: 18-APR-18
Milpitas CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silicone Personal Lubricant, ALL-IN-ONE
United Consortium 510(k) NO: K180083(Traditional)
ATTN: Stephanie Morris PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 09-APR-18
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrapLiner catheter
Vascular Solutions, Inc. 510(k) NO: K180088(Special)
ATTN: Beka Vite PHONE NO : 763 6575732
6464 Sycamore Court North SE DECISION MADE: 04-APR-18
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medacta Shoulder System Short Humeral Diaphysis
Medacta International SA 510(k) NO: K180089(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 05-APR-18
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cure™ Lumbar Plate System
Meditech Spine, LLC 510(k) NO: K180090(Special)
ATTN: Bruce Dunaway PHONE NO : 678 9745287
1447 Peachtree St NE Suite 440 SE DECISION MADE: 23-APR-18
Atlanta GA 30309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GDT-1000 System
AcuVu Inc. 510(k) NO: K180096(Traditional)
ATTN: Sam Mostafavi PHONE NO : 605 6706972
1749 Broadway Street SE DECISION MADE: 16-APR-18
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Embozene Color-Advanced Microspheres
Boston Scientific 510(k) NO: K180102(Traditional)
ATTN: Heidi Shearer PHONE NO : 763 2550056
3 Scimed Place SE DECISION MADE: 19-APR-18
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rafugen DBM
Cellumed Co., Ltd. 510(k) NO: K180121(Traditional)
ATTN: JooWoong (Albert) Jang PHONE NO : 82 2 21040475
#402, 130 Digital-ro Geumcheon-gu SE DECISION MADE: 11-APR-18
Seoul KR 153782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerLook Density Assessment Software
iCAD, Inc 510(k) NO: K180125(Traditional)
ATTN: John DeLucia PHONE NO : 603 3091945
98 Spitbrook Road Suite 100 SE DECISION MADE: 05-APR-18
Nashua NH 03062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOZO
ImpediMed Limited 510(k) NO: K180126(Traditional)
ATTN: Catherine Kingsford PHONE NO : 61 7 38603703
Unit 1 50 Parker Court SE DECISION MADE: 16-APR-18
Pinkenba AU 4008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProFlex Laser Fibers
InnovaQuartz LLC 510(k) NO: K180140(Traditional)
ATTN: Stephen E Griffin PHONE NO : 623 4341895
23030 North 15th Ave SE DECISION MADE: 20-APR-18
Phoenix AZ 85027-1315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ ICG Imaging System
KARL STORZ Endoscopy America, Inc.510(k) NO: K180146(Traditional)
ATTN: Winkie Wong PHONE NO : 424 2188379
2151 E. Grand Avenue SE DECISION MADE: 17-APR-18
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QiF Blood and Fluid Warmer
Quality In Flow Ltd. 510(k) NO: K180154(Special)
ATTN: Neta Sherman PHONE NO : 972 54 6600146
Kibutz Einat POB 29 SE DECISION MADE: 27-APR-18
Kibutz Einat IL 4880500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viz CTP
Viz.ai, Inc. 510(k) NO: K180161(Traditional)
ATTN: Gregory Ramina PHONE NO : 239 8983105
855 El Camino Real Suit 13A-252 SE DECISION MADE: 20-APR-18
Palo Alto CA 94301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESG-300, APU-300, Pressure Reducer, MAPC Probes
Olympus Winter & Ibe GmbH 510(k) NO: K180200(Traditional)
ATTN: Jan-Oliver Upmeier PHONE NO : 49 40 669662098
Kuehnstr. 61 SE DECISION MADE: 26-APR-18
Hamburg DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: neuromate Gen III
Renishaw Mayfield Sarl 510(k) NO: K180206(Traditional)
ATTN: Stephane Vinot PHONE NO : 011 33 437238900
31, Rue Ampere SE DECISION MADE: 24-APR-18
Chassieu FR 69680 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Endoscopic Trocar
Fengh Medical Co., Ltd. 510(k) NO: K180208(Traditional)
ATTN: Jun Zhou PHONE NO : 86 15 906171661
D3 No. 6 Dongsheng West Road, JianSE DECISION MADE: 09-APR-18
Jiangyin CN 214437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREO® Stabilization System
Globus Medical Inc. 510(k) NO: K180210(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 02-APR-18
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JO H2O Flavored Personal Lubricants
United Consortium 510(k) NO: K180219(Traditional)
ATTN: Stephanie Morris PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 20-APR-18
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reaxon Plus
Medovent GmbH 510(k) NO: K180222(Traditional)
ATTN: Peter Meier PHONE NO : 496 131 617690
Friedrich-Koenig-Str. 3 SE DECISION MADE: 24-APR-18
Mainz DE 55129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GSI Viewer with GSI Fat Option
GE Medical Systems SCS 510(k) NO: K180225(Traditional)
ATTN: Peter Uhlir PHONE NO : 00 36 14793318
283 rue de la Miniere SE DECISION MADE: 24-APR-18
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eviva Stereotactic Guided Breast Biopsy System
Hologic, Inc 510(k) NO: K180233(Traditional)
ATTN: Brenda M Geary PHONE NO : 508 2638819
250 Campus Drive SE DECISION MADE: 10-APR-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinity-Lock Button System
Xiros Ltd 510(k) NO: K180243(Traditional)
ATTN: Stephen Seed PHONE NO : 44 113 2387200
Springfield House, Whitehouse LaneSE DECISION MADE: 03-APR-18
Leeds GB LS17 7UE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
Crown Porcelain Dental Technology 510(k) NO: K180252(Traditional)
ATTN: Chu Lien Fan PHONE NO : 886 2 27324911 11
5F.-1, No. 189, Sec 2, Keelung Rd.SE DECISION MADE: 24-APR-18
Taipei City CN 110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InCore® Lapidus System
Nextremity Solutions, Inc. 510(k) NO: K180257(Traditional)
ATTN: Greg Denham PHONE NO : 732 3837901
210 North Buffalo Street SE DECISION MADE: 25-APR-18
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIO™ Surgical System (NAVIO system)
Blue Belt Technologies, Inc. 510(k) NO: K180271(Special)
ATTN: Corrine Herlinger PHONE NO : 763 4524950
2905 Northwest Blvd. Ste. 40 SE DECISION MADE: 06-APR-18
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
Smith & Nephew, Inc. 510(k) NO: K180277(Special)
ATTN: Allison Chan PHONE NO : 901 3991098
1450 Brooks Road SE DECISION MADE: 24-APR-18
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUVUE OASYS (senofilcon A) with Photochromic Additive
Johnson & Johnson Vision Care, Inc510(k) NO: K180299(Traditional)
ATTN: Victoria Brennand PHONE NO : 904 4433160
7500 Centurion Parkway, Suite 100 SE DECISION MADE: 10-APR-18
Jacksonville FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIS 5.5 Lumbar Pedicle Screw System
Axis Orthopaedics 510(k) NO: K180301(Traditional)
ATTN: Craig Wilcox PHONE NO : 907 2023111
34355 Poppy Wood SE DECISION MADE: 10-APR-18
Soldotna AK 99669 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Geri Embryo Incubator and Geri Dish
Genea Biomedx Pty Ltd 510(k) NO: K180304(Special)
ATTN: Kea Dent PHONE NO : 61 2 84847677
Level 2, 321 Kent Street SE DECISION MADE: 20-APR-18
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
Aquilabs US LLC 510(k) NO: K180305(Traditional)
ATTN: Juan Salcedo PHONE NO : 305 8852255
9205 NW 101st St. SE DECISION MADE: 13-APR-18
Medley FL 33178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mazor X
Mazor Robotics Ltd. 510(k) NO: K180307(Special)
ATTN: Shiran Conforti PHONE NO : 972 4 6187100
5 Shacham St. North Industrial ParSE DECISION MADE: 30-APR-18
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PET Digital Gating
GE Medical Systems, LLC 510(k) NO: K180318(Traditional)
ATTN: Lee Bush PHONE NO : 262 5482848
3000 N. Grandview Blvd. SE DECISION MADE: 11-APR-18
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: dpl IIa Panel
LED Technologies, Inc. 510(k) NO: K180320(Traditional)
ATTN: Lloyd Nelson PHONE NO : 303 6460543 117
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 03-APR-18
Greenwood Village CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
Visco Vision Inc. 510(k) NO: K180322(Traditional)
ATTN: Evan Huang PHONE NO : 866 3 3596868
No. 1, Xingye St. Guishan Dist. SE DECISION MADE: 20-APR-18
Taoyuan City TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patriot Spinal Fixation System
Valorus Spine 510(k) NO: K180324(Traditional)
ATTN: Leah Fero PHONE NO : 858 2459798
822 Hartz Way, Suite 230 SE DECISION MADE: 06-APR-18
Danville CA 94526 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClotTriever Thrombectomy System
Inari Medical 510(k) NO: K180329(Special)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 09-APR-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.MR Applications
Siemens Medical Solutions USA, Inc510(k) NO: K180336(Traditional)
ATTN: Cordell L Fields PHONE NO : 610 4486469
40 Liberty Boulevard Mailcode 65-1SE DECISION MADE: 19-APR-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
Liofilchem s. r. l. 510(k) NO: K180339(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 04-APR-18
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System
Steris Corporations 510(k) NO: K180342(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 04-APR-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TheraCal DC
Bisco, Inc. 510(k) NO: K180344(Special)
ATTN: Ryan Hobson PHONE NO : 847 5346000
1100 West Irving Park Road SE DECISION MADE: 05-APR-18
Schaumburg IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
Assure Tech (Hangzhou) Co., Ltd. 510(k) NO: K180349(Traditional)
ATTN: Shisheng Ling PHONE NO : 86 571 88868960
No. 10, Xiyuansan Rd., Westlake EcSE DECISION MADE: 05-APR-18
Hangzhou CN 310030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode laser hair removal device
Zhengzhou PZ Laser Slim Technology510(k) NO: K180353(Traditional)
ATTN: Zhou Hongwei PHONE NO : 86 187 36013788
Fl 2th, jia Tu zhi ye IntersectionSE DECISION MADE: 17-APR-18
High-tech Development Zone, Zhengz510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aurora Evacuator
Rebound Therapeutics 510(k) NO: K180372(Traditional)
ATTN: Jeffrey J. Valko PHONE NO : 949 3058111
13900 Alton Parkway, Suite 120 SE DECISION MADE: 09-APR-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K2M Patient Specific Rods
K2M, Inc. 510(k) NO: K180376(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
600 Hope Parkway SE SE DECISION MADE: 05-APR-18
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
Optomed Oy 510(k) NO: K180378(Traditional)
ATTN: Jyri Leskela PHONE NO : 358 20 7413380
Yrttipellontie 1 SE DECISION MADE: 05-APR-18
Oulu FI 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RayStation 7
RaySearch Laboratories AB (publ) 510(k) NO: K180379(Traditional)
ATTN: David Hedfors PHONE NO : 46 722 366110
Sveavagen 44 SE DECISION MADE: 25-APR-18
Stockholm SE 111 34 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal
Alcon Laboratories, Inc. 510(k) NO: K180398(Traditional)
ATTN: Sherri Lakota PHONE NO : 817 6155472
6201 South Freeway SE DECISION MADE: 10-APR-18
Fort Worth TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U60 Diagnostic Ultrasound System
Edan Instruments, Inc. 510(k) NO: K180408(Special)
ATTN: Crystal Cai PHONE NO : 86 755 26858736
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 13-APR-18
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
Cardiovascular Systems Inc. 510(k) NO: K180416(Traditional)
ATTN: Susan Wolf PHONE NO : 651 2024149
1225 Old Highway 8 NW SE DECISION MADE: 17-APR-18
Saint Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENNOVATE®
Aesculap Implant Systems, LLC 510(k) NO: K180433(Traditional)
ATTN: Melanie Burkert PHONE NO : 800 2581946
3773 Corporate Parkway SE DECISION MADE: 26-APR-18
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
Stryker Sustainability Solutions 510(k) NO: K180451(Traditional)
ATTN: Scott English PHONE NO : 480 7635333
1810 W Drake Drive SE DECISION MADE: 20-APR-18
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOCUS Pedicle Screw System
Nvision Biomedical Technologies, L510(k) NO: K180458(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
1350 N Loop 1604 E, Suite 103 SE DECISION MADE: 17-APR-18
San Antonio TX 78232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed LigaSure Maryland Jaw Sealer/Divider
Stryker Sustainability Solutions 510(k) NO: K180499(Traditional)
ATTN: Scott English PHONE NO : 480 7635333
1810 W Drake Drive SE DECISION MADE: 23-APR-18
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECICE STRYDE System
NuVasive Specialized Orthopedics, 510(k) NO: K180503(Special)
ATTN: Lance Justice PHONE NO : 949 5446540
101 Enterprise, Suite 100 SE DECISION MADE: 03-APR-18
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERITON NM
Spectrum Dynamics Medical Ltd. 510(k) NO: K180514(Traditional)
ATTN: Igor Naroditsky PHONE NO : 972 54 4384386
22 Bareket St. SE DECISION MADE: 25-APR-18
North Industrial Park IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Imager II Urology Torque Catheter
Boston Scientific Corporation 510(k) NO: K180530(Special)
ATTN: Daniel FitzDaniel PHONE NO : 508 6834156
100 Boston Scientific Way SE DECISION MADE: 10-APR-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
C.R. Bard, Inc (Bard has joined BD510(k) NO: K180548(Special)
ATTN: Bryan Stone PHONE NO : 801 5225876
605 North 5600 West SE DECISION MADE: 26-APR-18
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZED Link
Zed Technologies 510(k) NO: K180549(Traditional)
ATTN: Ronald Li PHONE NO : 61 13000 662980
12 Yarra Street, Office 105 SE DECISION MADE: 12-APR-18
South Yarra AU vic 3141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MobileX Portable X-ray System
Denterprise International, Inc. 510(k) NO: K180561(Traditional)
ATTN: Claude Berthoin PHONE NO : 877 5093180
100 E. Granada Blvd., Suite 219 SE DECISION MADE: 04-APR-18
Ormond Beach FL 32176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.plaza
Siemens Healthcare GmbH 510(k) NO: K180563(Third Party - Traditional)
ATTN: Vijay Ramadas PHONE NO : 49 172 4324369
Henkestrasse 127 SE DECISION MADE: 25-APR-18
Erlangen DE 91502 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Unite Connect for Clinical Systems
Ascom Sweden AB 510(k) NO: K180566(Special)
ATTN: Ivan Liljegren PHONE NO : 011 46 31559311
Grimbodalen 2 SE DECISION MADE: 03-APR-18
Goteborg SE se-402 76 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C3 Wave System
Medical Components, Inc. (dba Medc510(k) NO: K180567(Special)
ATTN: Courtney Nix PHONE NO : 215 2564201 2285
1499 Delp Drive SE DECISION MADE: 12-APR-18
Harleysville PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GammaPod
Xcision Medical Systems, LLC 510(k) NO: K180571(Special)
ATTN: Daniel R. Plonski PHONE NO : 443 6817468
9176 Red Branch Road SE DECISION MADE: 04-APR-18
Columbia MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
LPI, Inc. 510(k) NO: K180576(Traditional)
ATTN: Christopher Steadman PHONE NO : 423 3492920
506 Twin Oaks Drive SE DECISION MADE: 19-APR-18
Johnson City TN 37601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viveve RF System, Secure
Viveve Inc. 510(k) NO: K180584(Special)
ATTN: Suzon Lommel PHONE NO : 408 6454979
345 Inverness Dr S, Building B, SuSE DECISION MADE: 06-APR-18
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Varian Head Frame
Varian Medical Systems, Inc. 510(k) NO: K180586(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 02-APR-18
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device
Teleflex Medical 510(k) NO: K180588(Traditional)
ATTN: Ying Zhao PHONE NO : 919 3613941
3015 Carrington Mill Blvd. SE DECISION MADE: 17-APR-18
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR 800 with MUSICA Dynamic
Agfa HealthCare N.V. 510(k) NO: K180589(Traditional)
ATTN: Wim Govaerts PHONE NO : 32 3 4446246
Septestraat 27 SE DECISION MADE: 05-APR-18
Mortsel BE b-2640 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SciMoCa
Radialogica LLC 510(k) NO: K180595(Traditional)
ATTN: Debra Vigil PHONE NO : 800 5159132
511 N. 511 N. Garrison Avenue SE DECISION MADE: 04-APR-18
Saint Louis MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
Lumenis Ltd. 510(k) NO: K180597(Special)
ATTN: Amaya De Levie PHONE NO : 972 4 9599119
6 Hakidma Street P O Box 240 SE DECISION MADE: 03-APR-18
Yokneam IL 2069204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited 510(k) NO: K180614(Special)
ATTN: Lavinia Tompkins PHONE NO : 44 1482 225181
101 Hessle Road SE DECISION MADE: 06-APR-18
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
Contamac Ltd. 510(k) NO: K180616(Traditional)
ATTN: Rob McGregor PHONE NO : 44 1799 542000
Carlton House Shire Hall SE DECISION MADE: 25-APR-18
Saffron Walden GB CB11 3AU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited 510(k) NO: K180618(Special)
ATTN: Lavinia Tompkins PHONE NO : 44 1482 225181
101 Hessle Road SE DECISION MADE: 20-APR-18
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTFE SURGICAL SUTURE
OMNIA SPA 510(k) NO: K180630(Special)
ATTN: Roberto Cerioli PHONE NO : 0039 0524 527453
Via F. Delnevo, 190 SE DECISION MADE: 06-APR-18
Fidenza IT 43036 510(k) STATEMENT
DEVICE: ExactVu High Resolution Micro-Ultrasound System
Exact Imaging Inc. 510(k) NO: K180636(Third Party - Traditional)
ATTN: Randy AuCoin PHONE NO : 905 4150030
7676 Woodbine Avenue, Unit 15 SE DECISION MADE: 30-APR-18
Markham CA L3R 2N2 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: leva Pelvic Floor Trainer
Renovia Inc. 510(k) NO: K180637(Traditional)
ATTN: Gina Prochillo-Cawston PHONE NO : 866 7358424 1024
263 Summer St., 5th Floor SE DECISION MADE: 04-APR-18
Boston MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uroview FD II
Pausch Medical GmbH 510(k) NO: K180651(Traditional)
ATTN: Christian Stoian PHONE NO : 49 0 913199920
Graf-Zeppelin-StraBe 1 SE DECISION MADE: 12-APR-18
Erlangen DE d-91056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 48CH Head Coil
GE Healthcare Coils (USA Instrumen510(k) NO: K180666(Special)
ATTN: Veronica A. Meridith PHONE NO : 330 9955708
1515 Danner Drive SE DECISION MADE: 12-APR-18
Aurora OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartGrid
Carestream Health, Inc. 510(k) NO: K180667(Special)
ATTN: Diane Koetter PHONE NO : 585 6276505
150 Verona Street SE DECISION MADE: 13-APR-18
Rochester NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal
Alcon Laboratories, Inc. 510(k) NO: K180669(Traditional)
ATTN: Sherri Lakota PHONE NO : 817 6155472
6201 South Freeway SE DECISION MADE: 27-APR-18
Fort Worth TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surefire Spark Infusion System
Surefire Medical, Inc. 510(k) NO: K180677(Third Party - Traditional)
ATTN: Lynne Aronson PHONE NO : 720 3059877
6272 W. 91st Ave SE DECISION MADE: 03-APR-18
Westminster CO 80031 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CoaguChek XS Plus System
Roche Diagnostics 510(k) NO: K180684(Special)
ATTN: Bin Sun PHONE NO : 317 5213107
9115 Hague Road SE DECISION MADE: 19-APR-18
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
STERIS Corporation 510(k) NO: K180689(Special)
ATTN: Tony Piotrkowski PHONE NO : 440 3927437
5976 Heisley Road SE DECISION MADE: 12-APR-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoaguChek XS Pro System
Roche Diagnostics 510(k) NO: K180693(Special)
ATTN: Angie Clements PHONE NO : 317 5217338
9115 Hague Road SE DECISION MADE: 19-APR-18
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Spectranetics, Inc. 510(k) NO: K180694(Special)
ATTN: Travis Pittman PHONE NO : 719 4472470
9965 Federal Drive SE DECISION MADE: 05-APR-18
Colorado Springs CO 80921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
Medline Industries, Inc. 510(k) NO: K180696(Traditional)
ATTN: Pauline Maralit PHONE NO : 847 9492283
Three Lakes Drive SE DECISION MADE: 30-APR-18
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant Open Fusion Device
Applied Medical Resources Corporat510(k) NO: K180699(Special)
ATTN: Patricia Villarreal PHONE NO : 949 7136235
22872 Avenida Empresa SE DECISION MADE: 13-APR-18
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SonoSite iViz Ultrasound System
FUJIFILM SonoSite, Inc. 510(k) NO: K180704(Third Party - Abbreviated)
ATTN: Sudipta Chakrabarti PHONE NO : 425 9511371
21919 30th Drive SE SE DECISION MADE: 13-APR-18
Bothell WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PreludeSYNC DISTAL Radial Compression System
Merit Medical Systems, Inc 510(k) NO: K180723(Special)
ATTN: Susan Christensen PHONE NO : 801 2084789
1600 West Merit Parkway SE DECISION MADE: 17-APR-18
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultramatrix EUS Balloon
United States Endoscopy Group, Inc510(k) NO: K180731(Special)
ATTN: Coletta Cohara PHONE NO : 440 3586251
5976 Heisley Road SE DECISION MADE: 19-APR-18
Mentor OH 44060 510(k) STATEMENT
DEVICE: Stablyx CMC Arthroplasty Implant System
Skeletal Dynamics, LLC 510(k) NO: K180744(Special)
ATTN: Ana M. Escagedo PHONE NO : 305 5967585
8905 SW 87 Avenue, Suite 201 SE DECISION MADE: 11-APR-18
Miami FL 33176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: World Knee System
Signature Orthopaedics Pty Ltd. 510(k) NO: K180750(Special)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 20-APR-18
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafetyFix EasyOut System
SafetyFix Medical Technologies, In510(k) NO: K180753(Special)
ATTN: Michael Horwitz PHONE NO : 314 9830303
8637 Delmar Blvd SE DECISION MADE: 20-APR-18
St. Louis MO 63124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Televere Podiatry X-Ray System HF
Televere Systems, Inc. 510(k) NO: K180765(Traditional)
ATTN: Randell Quaal PHONE NO : 800 3859593
SE DECISION MADE: 20-APR-18
Arnold MD 21012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aria
GE Medical Systems Ultrasound & Pr510(k) NO: K180782(Traditional)
ATTN: Nicole Landreville PHONE NO : 289 2082365
3030 Ohmeda Drive SE DECISION MADE: 20-APR-18
Madison WI 53718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
Boston Scientific 510(k) NO: K180795(Special)
ATTN: Nikki M. Ibis PHONE NO : 763 4942381
Three Scimed Place SE DECISION MADE: 12-APR-18
Maple Grove MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genistrong
Genicon, Inc 510(k) NO: K180836(Special)
ATTN: Katlyn Kachman PHONE NO : 407 6574851
6869 Stapoint Court Suite 114 SE DECISION MADE: 18-APR-18
Winter Park FL 32792 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEX™ Reconstruction System
Medtronic Sofamor Danek USA, Inc 510(k) NO: K180851(Special)
ATTN: Ankit K Shah PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 18-APR-18
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic Model 53401 External Pulse Generator (EPG)
Medtronic, Inc. 510(k) NO: K180873(Special)
ATTN: Brenna Loufek PHONE NO : 763 5262365
8200 Coral Sea Street NE SE DECISION MADE: 19-APR-18
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aesculap Slim Clip Applier
Aesculap, Inc. 510(k) NO: K180914(Traditional)
ATTN: Paul Amudala PHONE NO : 1800 2581946
3773 Corporate Parkway SE DECISION MADE: 17-APR-18
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 262
TOTAL WITH SUMMARIES 246
TOTAL WITH STATEMENTS 16
