510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2018
DEVICE: AirSpiral Heated Breathing Tube
FISHER & PAYKEL HEALTHCARE 510(k) NO: K162553(Traditional)
ATTN: STEPHANIE ELVIN PHONE NO : 64 9 5740100
15 MAURICE PAYKEL PLACE, EAST TAMA SE DECISION MADE: 20-DEC-18
AUCKLAND NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RII Smart IR Thermometer
RADIANT INNOVATION INC. 510(k) NO: K163601(Traditional)
ATTN: Monica Chung PHONE NO : 886 3 6111666
1F, NO. 3 INDUSTRIAL E. 9TH RD SCI SE DECISION MADE: 06-DEC-18
HSIN CHU TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neck Care Therapy, Model: SYK 509B
Shenzhen OSTO Technology Co., Ltd. 510(k) NO: K172897(Traditional)
ATTN: Li Yang PHONE NO : 86 755 29769546
No.43 Longfeng Road, Xinsheng Comm SE DECISION MADE: 07-DEC-18
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Handheld VitalSigns Monitoring System
Visiomed Technology Co.,Ltd 510(k) NO: K172965(Traditional)
ATTN: Chen XiaoFeng PHONE NO : 07 55 29481701
2 Floor of No.1 Building, Jia An T SE DECISION MADE: 17-DEC-18
Bao An, Shenzhen, CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: North-vision Multi-parameter Patient Monitor
North-vision Tech. Inc. 510(k) NO: K173036(Traditional)
ATTN: Albert Huang PHONE NO : 886 3 5771038
1st Fl., No.15, Gongye E. 2nd Rd., SE DECISION MADE: 21-DEC-18
Hsinchu City TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3DIEMME RealGUIDE
3DIEMME Ltd. 510(k) NO: K173041(Traditional)
ATTN: Alessandro Montroni PHONE NO : 39 031 7073353
Via Risorgimento 9 SE DECISION MADE: 20-DEC-18
Cantu IT 22063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: No-contact Forehead Thermometer
Dongguan SIMZO Electronic Technolo 510(k) NO: K173048(Traditional)
ATTN: Mei Mei PHONE NO : 86 769 86339010
No.81, Tianxin Street, Chongkong, SE DECISION MADE: 06-DEC-18
Dongguan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANTER DENTAL PLANNING SOFTWARE
Implanter LLC 510(k) NO: K173083(Traditional)
ATTN: Jorge Millan PHONE NO : 786 4165587
2801 NE 183rd St #110W SE DECISION MADE: 03-DEC-18
Aventura FL 33160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System
VivaChek Laboratories, Inc. 510(k) NO: K173140(Traditional)
ATTN: Julie Zhou PHONE NO : 302 3398107
913 N Market Street, Suite 200 SE DECISION MADE: 19-DEC-18
Wilmington DE 19081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: reSET-O
Pear Therapeutics, Inc. 510(k) NO: K173681(Traditional)
ATTN: Yuri Maricich PHONE NO : 617 4337327
745 Atlantic Ave. SE DECISION MADE: 10-DEC-18
Boston MA 02111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REXLENE
SM ENG CO., LTD 510(k) NO: K173747(Traditional)
ATTN: Soon-Gu Lee PHONE NO : 82 51 3058016
46, Nakdong-daero 1302beon-gil SE DECISION MADE: 21-DEC-18
Sasang-gu KR 46910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMRA Profiler
AMRA Medical AB 510(k) NO: K173749(Traditional)
ATTN: Janne West PHONE NO : 46 13 162600
Badhusgatan 5 SE DECISION MADE: 06-DEC-18
Linkoping SE 58222 510(k) STATEMENT
DEVICE: SCIg60 Infusion System
EMED Technologies Corporation 510(k) NO: K173783(Traditional)
ATTN: Peter Kollings PHONE NO : 916 9320071
1264 Hawks Flight Ct, Suite 200 SE DECISION MADE: 14-DEC-18
El Dorado Hills CA 95762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Creme de La Femme Feminine Lubricant
Cewal, Inc. dba Premiere Enterpris 510(k) NO: K180014(Traditional)
ATTN: Jerome Vozoff PHONE NO : 310 8395000
2806 Oakhurst Avenue SE DECISION MADE: 21-DEC-18
Los Angeles CA 90034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SignalMark Lung Biopsy Site Marker
ViewPoint Medical, Inc. 510(k) NO: K180175(Traditional)
ATTN: Thomas Kane PHONE NO : 760 7077901
1235 Puerta del Sol #600 SE DECISION MADE: 07-DEC-18
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CranioMaxillofacial Fixation (CMF) System - CMF Visionare
Visionare LLC 510(k) NO: K180204(Traditional)
ATTN: Mariane de Oliveira Quinzan PHONE NO : 1 239 2442973
12251 Towne Lake Drive SE DECISION MADE: 28-DEC-18
Fort Meyers FL 33913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL-FR2000
BTL Industries, Inc. 510(k) NO: K180359(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 13-DEC-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: vital signs monitor
Edan Instruments, Inc. 510(k) NO: K180380(Traditional)
ATTN: Alice Yang PHONE NO : 86 755 26858736
#15 Jinhui Road,Jinsha Community K SE DECISION MADE: 21-DEC-18
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Procellera Composite Antibacterial Wound Dressing
Vomaris Wound Care, Inc. 510(k) NO: K180533(Traditional)
ATTN: Charmaine Sutton PHONE NO : 480 9214948
1911 East Fifth Street SE DECISION MADE: 10-DEC-18
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harvest Dental Polymer Blocks
Harvest Dental Products, LLC 510(k) NO: K180578(Traditional)
ATTN: Sasha Der Avanessian PHONE NO : 714 6747400
905 Columbia Street SE DECISION MADE: 12-DEC-18
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
Fresenius Kabi USA LLC 510(k) NO: K180615(Traditional)
ATTN: Kim Forch PHONE NO : 847 5507962
Three Corporate Drive SE DECISION MADE: 04-DEC-18
Lake Zurich IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spartan eCoil System
Spartan Micro, Inc 510(k) NO: K180653(Traditional)
ATTN: Mark Dias PHONE NO : 512 2708501
3167 Skyway Court SE DECISION MADE: 04-DEC-18
Freemont CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resin for Temporary Crown & Bridge
Dentis Co., Ltd. 510(k) NO: K180657(Traditional)
ATTN: Dong-Hun Jang PHONE NO : 82 53 5832804
6, Yuram-ro, Dong-gu SE DECISION MADE: 07-DEC-18
Daegu KR 41065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICONN Campbell Interference Screw
ICONN Orthopedics, LLC 510(k) NO: K180670(Traditional)
ATTN: Whitt Israel PHONE NO : 205 9132068
400 Union Hill Drive, Suite 150 SE DECISION MADE: 07-DEC-18
Birmingham AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
Global Scientific Technologies, LL 510(k) NO: K180679(Traditional)
ATTN: William J. Griswold, Jr. PHONE NO : 864 6553590
151 Old Jones Road SE DECISION MADE: 07-DEC-18
Greer SC 29651 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-Zero Pedicle Screw System, Freedom Pedicle Screw System
Signature Orthopaedics Pty Ltd. 510(k) NO: K180754(Traditional)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 07-DEC-18
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPI 3 HEMOGLOBIN(E)
SEBIA 510(k) NO: K180762(Traditional)
ATTN: Karen Anderson PHONE NO : 770 4463707 3704
1705 Corporate Drive, Suite 400 SE DECISION MADE: 14-DEC-18
Norcross GA 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SwiveLock Anchors
Arthrex Inc. 510(k) NO: K180768(Traditional)
ATTN: Jessica L. Singelais PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard SE DECISION MADE: 14-DEC-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Met One Czar Anterior Cervical Plate System
Met One Technologies 510(k) NO: K180772(Traditional)
ATTN: Evan Carbonell PHONE NO :
154 N. Festival Dr. Villa F SE DECISION MADE: 17-DEC-18
El Paso TX 79912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xcess Guiding Catheter
Curatia Medical Co. 510(k) NO: K180797(Traditional)
ATTN: Jessica Chiu PHONE NO : 408 4142188
3227 Kifer Road SE DECISION MADE: 14-DEC-18
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tono Vue Non-Contact Tonometer
Crystalvue Medical Corporation 510(k) NO: K180820(Traditional)
ATTN: Oliver Lin PHONE NO : 886 3 3607711
No. 116, Ln.956, Zhongshan Rd., Ta SE DECISION MADE: 14-DEC-18
Taoyuan TW 33072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruMatch Graft Cage - Long Bone
Synthes (USA) LLC 510(k) NO: K180821(Traditional)
ATTN: Christopher J. Medberry PHONE NO : 610 7196806
1301 Goshen Parkway SE DECISION MADE: 21-DEC-18
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Natrelle 133 Plus MICROCELL Tissue Expander
Allergan 510(k) NO: K180826(Traditional)
ATTN: Melissa Pathmajeyan PHONE NO : 714 2465919
2525 Dupont Drive SE DECISION MADE: 21-DEC-18
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Natureplex Warm Touch Warming Jelly
Natureplex, LLC 510(k) NO: K180828(Traditional)
ATTN: Pamela Hopkins PHONE NO : 662 8741206
11085 Airport Road SE DECISION MADE: 20-DEC-18
Olive Branch MS 38654 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reuter Tip Deflecting Wire Guide
Cook Incorporated 510(k) NO: K180830(Traditional)
ATTN: Jennifer L. Allman PHONE NO : 812 3353575 104280
750 Daniels Way SE DECISION MADE: 20-DEC-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATSmart
Fresenius Kabi AG 510(k) NO: K180831(Traditional)
ATTN: Barry G. Hicks PHONE NO : 49 6172 6860
Else-Kroner-Strasse 1 SE DECISION MADE: 10-DEC-18
Bad Homburg DE 61352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arterial Pressure Monitoring Set/Tray
Cook Incorporated 510(k) NO: K180846(Traditional)
ATTN: Johnathan Liu PHONE NO : 812 3353575 104509
750 Daniels Way SE DECISION MADE: 19-DEC-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PYRAMIDION Dental Implants and Prostheses
DenTack Implants Ltd 510(k) NO: K180859(Traditional)
ATTN: Tali Hazan PHONE NO : 972 50 5292304
24 HaTa'as St. POB 2405 SE DECISION MADE: 13-DEC-18
Kfar-Saba IL 4464102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
TaiDoc Technology Corporation 510(k) NO: K180863(Traditional)
ATTN: Sylvia Liu PHONE NO : 886 2 66258188 6134
6F, No.127, Wugong 2nd Rd., Wugu D SE DECISION MADE: 19-DEC-18
New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AmCAD-UO
AmCad BioMed Corporation 510(k) NO: K180867(Traditional)
ATTN: Jack Yang PHONE NO : 886 2 27136227
FL. 5-2, No. 167, Fu Hsing N. RD. SE DECISION MADE: 28-DEC-18
Taipei TW 105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use
Shanghai Venture Bio-Tech CO., Ltd 510(k) NO: K180878(Traditional)
ATTN: Longli Long PHONE NO : 86 21 34621799
Room 313, Building 2, No. 2715 Lon SE DECISION MADE: 17-DEC-18
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
SHANGHAI VENTURE BIO-TECH CO., LTD 510(k) NO: K180879(Traditional)
ATTN: Longli Long PHONE NO : 86 21 34621799
Room 313, Building 2, No. 2715 Lon SE DECISION MADE: 14-DEC-18
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tractus Crossing Support Catheter
Tractus Vascular LLC 510(k) NO: K180889(Traditional)
ATTN: Janet Burpee PHONE NO : 732 9968513
15 Christopher Way SE DECISION MADE: 07-DEC-18
Eatontown NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVEL Spacers
Globus Medical Inc. 510(k) NO: K180909(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Avenue SE DECISION MADE: 18-DEC-18
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUTRONIC GENIUS Radiofrequency System
Lutronic Corporation 510(k) NO: K180945(Traditional)
ATTN: Jhung Won Vojir PHONE NO : 82 31 9083440
Lutronic Center, 219, Sowon-ro SE DECISION MADE: 10-DEC-18
Deogyang-gu, Goyang-si KR 410220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mygen V-1000 RF System
RF Medical Co., Ltd 510(k) NO: K180999(Traditional)
ATTN: Kwang S. Choi PHONE NO : 82 2 21084200
#502, 503, 506, 511, 254, Beotkkot SE DECISION MADE: 11-DEC-18
Seoul KR 510(k) STATEMENT
DEVICE: DIO CAD/CAM Abutment
DIO Corporation 510(k) NO: K181037(Traditional)
ATTN: Jiae Park PHONE NO : 82 51 7457836
66, Centum Seo-ro, Haeundae-gu SE DECISION MADE: 21-DEC-18
Busan KR 48058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apex Locator, DPEX III
Guilin Woodpecker Medical Instrume 510(k) NO: K181087(Traditional)
ATTN: Xunxian Wu PHONE NO : 86 773 2269636
Information Industrial Park, Guili SE DECISION MADE: 18-DEC-18
Guilin City CN 541004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elevo® Kit Snoring Intervention Device
Zelegent, Inc. 510(k) NO: K181107(Traditional)
ATTN: David C. Humbert PHONE NO : 650 7638282
5151 California Avenue SE DECISION MADE: 06-DEC-18
Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.8 mm/3.3 mm PopLok Suture Anchors
ConMed Corporation 510(k) NO: K181120(Special)
ATTN: Diana L. Nader-Martone PHONE NO : 727 3995264
525 French Road SE DECISION MADE: 21-DEC-18
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accu-Chek Guide Me Blood Glucose Monitoring System
Roche Diabetes Care 510(k) NO: K181131(Special)
ATTN: Ginger Emrich PHONE NO : 317 5214037
9115 Hague Road SE DECISION MADE: 13-DEC-18
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LZI Fentanyl Enzyme Immunoassay
Lin-Zhi International, Inc. 510(k) NO: K181159(Traditional)
ATTN: Bernice Lin PHONE NO : 408 9708811
2945 Oakmead Village Court SE DECISION MADE: 03-DEC-18
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardinal Health Sterilization Wrap
Cardinal Health 200 LLC 510(k) NO: K181174(Traditional)
ATTN: Jillian Connery PHONE NO : 614 7574045
3651 Birchwood Drive SE DECISION MADE: 11-DEC-18
Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes T-PAL Spacer System
DePuy Synthes Spine 510(k) NO: K181231(Traditional)
ATTN: Heta Shah PHONE NO : 508 9773966
325 Paramount Drive SE DECISION MADE: 06-DEC-18
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iCertainty
Rfpi 510(k) NO: K181269(Traditional)
ATTN: Jeffery Basham PHONE NO : 919 2802953
1800 N Greene Street, Suite K SE DECISION MADE: 14-DEC-18
Greenville NC 27834 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Honda Walking Assist Device
Honda Motor Company, Ltd. 510(k) NO: K181294(Traditional)
ATTN: Kazushi Hamaya PHONE NO : 81 80 49004527
1-4-1 Chuo SE DECISION MADE: 14-DEC-18
Wako-shi JP 351-0193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White
Juvora, Ltd. 510(k) NO: K181331(Traditional)
ATTN: Tim Leyva PHONE NO : 484 3544185
Technology Centre, Hillhouse Inter SE DECISION MADE: 21-DEC-18
Thornton-Clevelys GB FY5 4QD 510(k) STATEMENT
DEVICE: HS50 / HS60 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K181336(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 04-DEC-18
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M Mobility Scooter
CHIEN TI ENTERPRISE CO., LTD. 510(k) NO: K181344(Traditional)
ATTN: Vivian Lo PHONE NO : 886 2 29032987
No. 13, Lane 227, Fu Ying Rd SE DECISION MADE: 14-DEC-18
New Taipei City, Hsin Chuang Distr 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
Globus Medical Inc. 510(k) NO: K181357(Traditional)
ATTN: Kelly Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 06-DEC-18
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Argos
Retia Medical, LLC 510(k) NO: K181372(Traditional)
ATTN: Marc Zemel PHONE NO : 914 5941986
7 Dana Rd. Suite 111 SE DECISION MADE: 13-DEC-18
Valhalla NY 10595 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NRFit Syringe
Jiangsu Caina Medical Co., Ltd 510(k) NO: K181374(Traditional)
ATTN: Jun Lu PHONE NO : 86 510 86205183
No. 23, Huanxi Road, Zhutang Town SE DECISION MADE: 14-DEC-18
Jiangyin CN 214421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hailie Sensor
Adherium (NZ) Ltd 510(k) NO: K181405(Traditional)
ATTN: Chris Mander PHONE NO : 64 9 3072771
Level 2, 204 Quay Street SE DECISION MADE: 10-DEC-18
Auckland NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK MS
bioMerieux, Inc. 510(k) NO: K181412(Traditional)
ATTN: Jennifer Jines PHONE NO : 314 7318352
595 Anglum Rd. SE DECISION MADE: 21-DEC-18
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DuraSheath Introducer Sheath System
Contract Medical International Gmb 510(k) NO: K181463(Traditional)
ATTN: Jan Kloboucnik PHONE NO : 49 3512138888
Lauensteiner Str. 37 SE DECISION MADE: 13-DEC-18
Dresden DE 01277 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINTAGE PRO
Shofu Dental Corporation 510(k) NO: K181496(Traditional)
ATTN: Mauro Malzyner PHONE NO : 760 7363277 202
1225 Stone Drive SE DECISION MADE: 18-DEC-18
San Marcos CA 92078 510(k) STATEMENT
DEVICE: X-ray Imaging System for the McLaren Proton Treatment System
EhmetDx, LLC 510(k) NO: K181498(Traditional)
ATTN: Daniel Schoettlin PHONE NO : 614 9057161
47801 W Anchor Ct SE DECISION MADE: 10-DEC-18
Plymouth MI 48170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
Contego Medical, LLC 510(k) NO: K181529(Traditional)
ATTN: Elizabeth Saylors PHONE NO : 919 4597250
3921 Sunset Ridge Rd., Suite 102 SE DECISION MADE: 06-DEC-18
Raliegh NC 27607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Fracture Adapter Hemi Shoulder Prosthesis
Arthrex Inc. 510(k) NO: K181555(Traditional)
ATTN: David L. Rogers PHONE NO : 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 21-DEC-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
Flexicare Medical Limited 510(k) NO: K181583(Third Party - Traditional)
ATTN: Joel Biddle PHONE NO : 44 1443 474560
Cynon Valley Business Park SE DECISION MADE: 07-DEC-18
Mountain Ash GB cf45 4ER 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Curiteva Lumbar Interbody Fusion System
Curiteva, LLC 510(k) NO: K181589(Traditional)
ATTN: Eric Linder PHONE NO : 256 2131057
25127 Will McComb Drive, Suite 100 SE DECISION MADE: 20-DEC-18
Tanner AL 35671 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyto Stethoscope (OTC)
Tyto Care Ltd. 510(k) NO: K181612(Third Party - Traditional)
ATTN: Stella Raizelman Perry PHONE NO : 972 72 2210750
12 Haomanut Street SE DECISION MADE: 17-DEC-18
Netanya IL 4250445 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Life Spine Resolute™ Threaded Cage System
Life Spine Inc. 510(k) NO: K181625(Traditional)
ATTN: Angela Batke PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 11-DEC-18
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuikClot Radial
Z-Medica, LLC 510(k) NO: K181641(Traditional)
ATTN: Sheila K. Wallin PHONE NO : 203 7747922
4 Fairfield Boulevard SE DECISION MADE: 24-DEC-18
Wallingford CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
GenMark Diagnostics, Incorporated 510(k) NO: K181663(Traditional)
ATTN: Alan Maderazo PHONE NO : 760 4484308
5964 La Place Court SE DECISION MADE: 20-DEC-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
TaiDoc Technology Corporation 510(k) NO: K181675(Traditional)
ATTN: Yvette Chang PHONE NO : 866 2 66258188
B1-7F, No. 127, Wugong 2nd Rd., Wu SE DECISION MADE: 10-DEC-18
New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear-Jet Injection Catheter
Finemedix Co. Ltd. 510(k) NO: K181690(Traditional)
ATTN: Hee Kyung Kwon PHONE NO : 82 53 7418388
60, Maeyeo-ro, Dong-gu SE DECISION MADE: 21-DEC-18
Daegu KR 41065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nihon Kohden NKV-550 Series Ventilator System
Nihon Kohden OrangeMed, Inc. 510(k) NO: K181695(Traditional)
ATTN: Sheryl Higgins PHONE NO : 949 5026448
1800 E. Wilshire Ave. SE DECISION MADE: 07-DEC-18
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
Institut Straumann AG 510(k) NO: K181703(Traditional)
ATTN: Viviana Horhoiu PHONE NO : 41 61 9651512
Peter Merian Weg 12 SE DECISION MADE: 28-DEC-18
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid iq
GE Medical Systems Ultrasound and 510(k) NO: K181727(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W. Innovation Drive SE DECISION MADE: 06-DEC-18
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BI-MENTUM dual mobility system
Serf 510(k) NO: K181744(Traditional)
ATTN: Jean-Lus Aurelle PHONE NO : 33 472 056010
85 Avenue des Bruyeres SE DECISION MADE: 11-DEC-18
Decines FR 69150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
Stryker Corporation 510(k) NO: K181752(Traditional)
ATTN: Kristi Ashton PHONE NO : 269 3895929
4100 E. Milham Avenue SE DECISION MADE: 21-DEC-18
Kalamazoo MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
AprioMed AB 510(k) NO: K181756(Traditional)
ATTN: Katrin Svensson PHONE NO : 46 184 301440
Virdings Alle 28 SE DECISION MADE: 18-DEC-18
Uppsala SE 75450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Biomet Select Ceramic Heads
Zimmer, Inc 510(k) NO: K181761(Traditional)
ATTN: Carol Vierling PHONE NO : 706 4762938
PO Box 708 SE DECISION MADE: 26-DEC-18
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
bioMerieux, Inc 510(k) NO: K181766(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 10-DEC-18
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Modified BrainScope One
BrainScope Company Inc. 510(k) NO: K181785(Traditional)
ATTN: Michael E Singer PHONE NO : 240 7527680
4350 East West Hwy, Ste 1050 SE DECISION MADE: 19-DEC-18
Bethesda MD 20814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CBT Screw Fixation System
U&i Corporation 510(k) NO: K181824(Traditional)
ATTN: Jee-Ae Bang PHONE NO : 82 31 8606846
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 13-DEC-18
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAAS MR Solutions
Pie Medical Imaging B.V. 510(k) NO: K181825(Traditional)
ATTN: Annemiek Bouts PHONE NO : 31 433 281328
Philipsweg 1 SE DECISION MADE: 04-DEC-18
Maastricht NL 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glenoid Polyaxial Non-locking Screws
Medacta International SA 510(k) NO: K181826(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 10-DEC-18
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affixus Natural Nail System Humeral Nail
Zimmer GmbH 510(k) NO: K181827(Traditional)
ATTN: Robert Tommasini PHONE NO : 41 58 8548264
Sulzerallee 8 SE DECISION MADE: 14-DEC-18
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sinusway Dilation System
3NT Medical Ltd. 510(k) NO: K181838(Traditional)
ATTN: Ehud Bendory PHONE NO : 972 737154057
22 Hamelacha Street PO Box 11384 SE DECISION MADE: 20-DEC-18
Rosh Ha'ayin IL 4809169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Embrace
Empatica Srl 510(k) NO: K181861(Traditional)
ATTN: Simone Tognetti PHONE NO : 0039 334 3078626
Via Stendhal 36 SE DECISION MADE: 20-DEC-18
Milano IT 20144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acu-sInQ Complete Endoscope Cleaning Aid System
STERIS Corporation 510(k) NO: K181865(Traditional)
ATTN: Gregory Land PHONE NO : 440 3927424
5960 Heisley Road SE DECISION MADE: 14-DEC-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: On1 Universal Abutment
Nobel Biocare AB 510(k) NO: K181869(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
Box 5190, SE-402 26, Vastra Hamnga SE DECISION MADE: 12-DEC-18
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phoenix 2.4mm Atherectomy Plus System
Volcano AtheroMed Inc. 510(k) NO: K181877(Traditional)
ATTN: Jean Chang PHONE NO : 650 3525255
1530 O'Brien Drive Suite A SE DECISION MADE: 17-DEC-18
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCCIA® PLIF
Silony Medical GmbH 510(k) NO: K181899(Traditional)
ATTN: Bircan Tasdelen PHONE NO : 49 711 7825250
Leinfelder Strasse 60 SE DECISION MADE: 13-DEC-18
Leinfelden-Echterdingen DE 70771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Action Trackchair
Action Manufacturing Inc. 510(k) NO: K181908(Traditional)
ATTN: Alan Macht PHONE NO : 507 5325940
1105 Lake Road SE DECISION MADE: 03-DEC-18
Marshall MN 56258 510(k) STATEMENT
DEVICE: Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
CooperVision, Inc. 510(k) NO: K181920(Traditional)
ATTN: Marie Dutton PHONE NO : 925 2516645
5870 Stoneridge Drive Suite 1 SE DECISION MADE: 11-DEC-18
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoform Reconstructive Template - Non Absorbable
Aroa Biosurgery Ltd. 510(k) NO: K181935(Traditional)
ATTN: Tina O'Brien PHONE NO : 64 09 8693035
2 Kingsford Smith Place SE DECISION MADE: 04-DEC-18
Airport Oaks NZ 2022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MagnetOs Putty
Kuros Biosciences B.V. 510(k) NO: K181958(Traditional)
ATTN: Yvonne P. Bovell PHONE NO : 31 30 2297280
Professor Bronkhorstlaan 10, build SE DECISION MADE: 06-DEC-18
Bilthoven NL 3723 MB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Temperature Probe
Shenzhen Launch Electrical Co., LT 510(k) NO: K181967(Traditional)
ATTN: Jiaan Huang PHONE NO : 86 755 29532401
No.F Building, Zhonggangxing Indus SE DECISION MADE: 10-DEC-18
Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaLIF Posterior Extension
Medacta International SA 510(k) NO: K181970(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 04-DEC-18
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acucy Influenza A&B Test with the Acucy System
Sekisui Diagnostics, LLC 510(k) NO: K182001(Dual Track)
ATTN: Shelly Harris PHONE NO : 858 7772627
6659 Top Gun St. SE DECISION MADE: 17-DEC-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
Hologic, Inc 510(k) NO: K182006(Special)
ATTN: Rachelle D. Fitzgerald PHONE NO : 508 2638631
250 Campus Drive SE DECISION MADE: 06-DEC-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
Renovis Surgical Technologies 510(k) NO: K182007(Traditional)
ATTN: Anthony DeBenedictis PHONE NO : 909 5572360
1901 W. Lugonia Ave., Suite 340 SE DECISION MADE: 07-DEC-18
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phasix ST Mesh with Echo 2 Positioning System
CR Bard Inc. 510(k) NO: K182008(Traditional)
ATTN: Shirin Mate PHONE NO : 401 8258569
100 Crossing Boulevard SE DECISION MADE: 14-DEC-18
Warwick RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur Calcitonin (CALCT) assay
Axis-Shield Diagnostics Limited 510(k) NO: K182012(Traditional)
ATTN: Claire Dora PHONE NO : 44 01382 422000
Luna Place, The Technology Park SE DECISION MADE: 21-DEC-18
Dundee GB DD2 1XA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simplicit90Y
Mirada Medical Ltd. 510(k) NO: K182016(Traditional)
ATTN: Sarah Bond PHONE NO : 44 01865 261410
Oxford Center for Innovation, New SE DECISION MADE: 06-DEC-18
Oxford GB ox1 1by 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SterilContainer S System
Aesculap, Inc. 510(k) NO: K182032(Traditional)
ATTN: Paul Amudala PHONE NO : 800 2581946
3773 Corporate Parkway SE DECISION MADE: 21-DEC-18
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FFRct
HeartFlow, Inc 510(k) NO: K182035(Special)
ATTN: Windi Hary PHONE NO : 650 2411250
1400 Seaport Boulevard Building B SE DECISION MADE: 06-DEC-18
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
YD Diagnostics Corporation 510(k) NO: K182038(Traditional)
ATTN: Hyuckjoo Lee PHONE NO : 82 31 3292000
76, Seori-ro, Idong-myeon, Cheoin- SE DECISION MADE: 10-DEC-18
Yongin-si KR 17127 510(k) STATEMENT
DEVICE: Lotus III Multi-Pulsed Er: Yag Laser System
Laseroptek Co., Ltd. 510(k) NO: K182045(Third Party - Traditional)
ATTN: Hong Chu PHONE NO : 82 31 80235150
#116, #117, #203, #204, Hyundai I SE DECISION MADE: 27-DEC-18
Seongnam-Si KR 13212 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Avenir Complete Hip System
Zimmer, Inc 510(k) NO: K182048(Traditional)
ATTN: Rebecca D Noftz PHONE NO : 574 3732934
P.O. Box 708 SE DECISION MADE: 07-DEC-18
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUX CAD/CAM PMMA BLOCKS
Blue Dent Dental 510(k) NO: K182065(Traditional)
ATTN: Adriana Paula T I Gomes PHONE NO : 55 19 35632222
Rua: Joaquim Jorge Port 1272 SE DECISION MADE: 13-DEC-18
Pirassununga BR 13636142 510(k) STATEMENT
DEVICE: Erran Dental Zirconia
Hangzhou Erran Technology Co., Ltd 510(k) NO: K182068(Traditional)
ATTN: Tingkai Li PHONE NO : 0571 88036310
Room F3022, Floor 3, Building 1 (s SE DECISION MADE: 13-DEC-18
Hangzhou CN 310053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
Shenzhen Mindray Bio-medical Elect 510(k) NO: K182075(Traditional)
ATTN: Yanhong Bai PHONE NO : 86 755 81888998
Mindray Building, Keji 12th Road S SE DECISION MADE: 10-DEC-18
Shenzhen TW 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elekta Unity
Elekta Limited 510(k) NO: K182076(Traditional)
ATTN: Nicholas Power PHONE NO : 0044 1293 654422
Fleming Way SE DECISION MADE: 04-DEC-18
Crawley GB RH10 9RR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Delta TT Pro
Limacorporate S.p.A. 510(k) NO: K182099(Traditional)
ATTN: Roberto Gabetta PHONE NO : 39 043 2945511
via Nazionale 52 SE DECISION MADE: 26-DEC-18
Villanova di San Daniele IT 33038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BA310 Abutment, BIA310 Implant/Abutment
Cochlear Americas 510(k) NO: K182116(Traditional)
ATTN: Beth Murray PHONE NO : 1 800 5265798
13059 E. Peakview Ave. SE DECISION MADE: 19-DEC-18
Centennial CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION Stemmed CS Femur
MicroPort Orthopedics Inc. 510(k) NO: K182125(Traditional)
ATTN: Hunter Ethan Williams PHONE NO : 901 4516511
5677 Airline Road SE DECISION MADE: 06-DEC-18
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSchemaView RAPID
iSchemaView, Inc. 510(k) NO: K182130(Traditional)
ATTN: Jim Rosa PHONE NO : 650 3889767
201 Marshall Street, Ste. 101 SE DECISION MADE: 27-DEC-18
Redwood City CO 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
Sol-Millennium Medical, Inc. 510(k) NO: K182146(Traditional)
ATTN: James Barley PHONE NO : 949 4333058
1735 North Brown Road, Suite 120 SE DECISION MADE: 03-DEC-18
Lawrenceville GA 30043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FFRangio System
CathWorks Ltd 510(k) NO: K182149(Traditional)
ATTN: Miriam Ivenshitz PHONE NO : 972 97467387
3 Rapaport Street SE DECISION MADE: 19-DEC-18
Kfar-Saba IL 4465141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Devon 52 Sequential Compression Device
Devon Medical Products (Jiangsu) L 510(k) NO: K182150(Special)
ATTN: Neil Cheng PHONE NO : 86 513 51080988
East Half of 1-2F, Appt D2, 1, Qin SE DECISION MADE: 18-DEC-18
Nantong CN 226017 510(k) STATEMENT
DEVICE: Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Syntex Healthcare Products Co., Lt 510(k) NO: K182156(Traditional)
ATTN: Qiao Zhiqiang PHONE NO : 86 311 66179653
No. 1, Fanjiazhuang, Industrial Zo SE DECISION MADE: 10-DEC-18
Xinji City CN 052360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Color Doppler Ultrasound System; Model: mEye1 and mEye2
Shenzhen Well.D Medical Electronic 510(k) NO: K182165(Traditional)
ATTN: Ning Bai PHONE NO : 86 755 36900033
Well.d Park, Qinglan 3 Rd, Nationa SE DECISION MADE: 20-DEC-18
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The ICHOR Panacea Vascular Embolectomy Catheter System
ICHOR Vascular, Inc. 510(k) NO: K182167(Traditional)
ATTN: Jeff Blair PHONE NO : 651 2104766
2865 N Reynolds Rd Suite 220A SE DECISION MADE: 21-DEC-18
Toledo OH 43615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: neoBLUE blanket LED Phototherapy System
Natus Medical Incorporated 510(k) NO: K182178(Traditional)
ATTN: Judy Buckham PHONE NO : 800 4260353 5187
5900 First Avenue South SE DECISION MADE: 13-DEC-18
Seattle WA 98108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A
Samsung Electronics Co., LTD. 510(k) NO: K182183(Traditional)
ATTN: Jaesang Noh PHONE NO : 82 2 21932444
129, Samsung-Ro, Yeongtong-Gu SE DECISION MADE: 07-DEC-18
Suwon-Si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fetal Doppler
Shenzhen AOJ Medical Technology Co 510(k) NO: K182190(Traditional)
ATTN: Qihuan Zhao PHONE NO : 86 18 603031299
Room 202, HaoGu Industry Park, 203 SE DECISION MADE: 19-DEC-18
Shenzhen CN 518105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UV Active Implant System
DIO Corporation 510(k) NO: K182194(Traditional)
ATTN: Park Jiae PHONE NO : 82 51 7457836
66, Centum Seo-ro, Haeundae-gu SE DECISION MADE: 14-DEC-18
Busan KR 48058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TR90BH
MinXray, Inc 510(k) NO: K182207(Traditional)
ATTN: Keith Kretchmer PHONE NO : 847 5640323
3611 Commercial Ave SE DECISION MADE: 14-DEC-18
Northbrook IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VO200 – NeurOs Cerebral Oximetry System
Mespere LifeSciences Inc. 510(k) NO: K182242(Traditional)
ATTN: Rebecca S. Li PHONE NO : 519 8847575 1
180 Frobisher Drive, Suite 1C SE DECISION MADE: 26-DEC-18
Waterloo CA N2V 2A2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARK Tramadol Assay
ARK Diagnostics, Inc. 510(k) NO: K182280(Traditional)
ATTN: Cherry Mun PHONE NO : 510 2706288
48089 Fremont Boulevard SE DECISION MADE: 10-DEC-18
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HyperFil-LV
Parkell, Inc. 510(k) NO: K182296(Traditional)
ATTN: David Mott PHONE NO : 631 3891545
300 Executive Drive SE DECISION MADE: 14-DEC-18
Edgewood NY 11717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Contoured Base Pen Needle
Becton, Dickinson and Company 510(k) NO: K182320(Traditional)
ATTN: Meriam Youssef PHONE NO : 201 8476557
1 Becton Drive SE DECISION MADE: 20-DEC-18
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEUCADIA AUTOLOK™ Pedicle Screw System
ClearView Orthopedic Development, 510(k) NO: K182339(Special)
ATTN: Hartmut Loch PHONE NO : 949 7527885 104
15550-D Rockfield Blvd SE DECISION MADE: 12-DEC-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeAir Telescopic Smoke Pencil
LiNA Medical ApS 510(k) NO: K182354(Traditional)
ATTN: Natalia Szychulska PHONE NO : 48 61 2222121
Formervangen 5 SE DECISION MADE: 14-DEC-18
Glostrup DK 2600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HipCheck
Stryker Corp. 510(k) NO: K182359(Traditional)
ATTN: Cara Mellits PHONE NO : 408 7542367
5900 Optical Ct SE DECISION MADE: 13-DEC-18
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Compression FT Screws
Arthrex Inc. 510(k) NO: K182361(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 18-DEC-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Compression FT Screws
Arthrex Inc. 510(k) NO: K182361(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 18-DEC-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Compression FT Screws
Arthrex Inc. 510(k) NO: K182361(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 18-DEC-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerLook Tomo Detection V2 Software
iCAD Inc. 510(k) NO: K182373(Traditional)
ATTN: John DeLucia PHONE NO : 603 3091945
98 Spitbrook Rd. Suite 100 SE DECISION MADE: 06-DEC-18
Nashua NH 03062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
Novo Nordisk Inc. 510(k) NO: K182387(Traditional)
ATTN: Elizabeth D'Amato PHONE NO : 609 9197789
800 Scudders Mill Rd SE DECISION MADE: 17-DEC-18
Plainsboro NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Cardiovascular Systems Inc. 510(k) NO: K182397(Traditional)
ATTN: Kris Miller PHONE NO : 651 2591656
1225 Old Highway 8 NW SE DECISION MADE: 13-DEC-18
St. Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD VELOCITY Biological Indicator
Advanced Sterilization Products (A 510(k) NO: K182404(Traditional)
ATTN: Sun Choi PHONE NO : 949 4536378
33 Technology Drive SE DECISION MADE: 27-DEC-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Centricity Universal Viewer
GE Healthcare 510(k) NO: K182419(Traditional)
ATTN: Renee Webb PHONE NO : 847 7078783
500 West Monroe Street SE DECISION MADE: 14-DEC-18
Chicago IL 60661-3671 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI Corsair Pro XS
Asahi Intecc Co., Ltd. 510(k) NO: K182420(Traditional)
ATTN: Yasuyuki Kawahara PHONE NO : 81 561 485551
3-100 Akatsuki-cho SE DECISION MADE: 20-DEC-18
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucitone Denture Base Materials
Dentsply Sirona 510(k) NO: K182422(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, Suit SE DECISION MADE: 18-DEC-18
York PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuFACE FIX Skin Toning Device
Carol Cole Company dba NuFACE 510(k) NO: K182424(Traditional)
ATTN: Donald Ellis PHONE NO : 760 5091264
1325 Sycamore Ave. Suite A SE DECISION MADE: 18-DEC-18
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
Shenzhen Caremed Medical Technolog 510(k) NO: K182433(Traditional)
ATTN: Alan Xie PHONE NO : 86 755 36560977 889
East Side, 3/F, C Building, Kelunt SE DECISION MADE: 17-DEC-18
Dalang Office, Longhua District, S 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LaparoGuard
Mariner Endosurgery Inc. 510(k) NO: K182434(Traditional)
ATTN: Mitch Wilson PHONE NO : 1 905 9218755
305A, 175 Longwood Road South SE DECISION MADE: 13-DEC-18
Hamilton CA L8P 0A1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synthetic Polyisoprene Lubricated Male Condom - 5 senses
Sxwell Usa LLC 510(k) NO: K182438(Abbreviated)
ATTN: Robert Mahler PHONE NO : 732 3452174
111 Wood Avenue South SE DECISION MADE: 06-DEC-18
Iselin NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruShot with Y-Knot All-Suture Anchor
ConMed Corporation 510(k) NO: K182446(Special)
ATTN: Diana L. Nader-Martone PHONE NO : 727 3995425
525 French Road SE DECISION MADE: 19-DEC-18
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O2 Concepts Oxlife Independence Model 301-0001
O2 Concepts LLC 510(k) NO: K182454(Third Party - Traditional)
ATTN: Kathryn G. Forgione PHONE NO : 877 8674008 368
199 Park Road Extension SE DECISION MADE: 20-DEC-18
Middlebury CT 06762 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LATITUDE EV Total Elbow Arthroplasty
Tornier Inc. 510(k) NO: K182461(Traditional)
ATTN: Renee Stoffel PHONE NO : 952 6837471
10801 Nesbitt Ave South SE DECISION MADE: 27-DEC-18
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems
K2M Inc. 510(k) NO: K182473(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
600 Hope Pkwy. SE SE DECISION MADE: 12-DEC-18
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
Hycor Biomedical 510(k) NO: K182479(Traditional)
ATTN: Tara Viviani PHONE NO : 714 9333027
7272 Chapman Avenue SE DECISION MADE: 04-DEC-18
Garden Grove CA 92841 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Applanation tonometer AT-2
Takagi Seiko Co., Ltd. 510(k) NO: K182491(Traditional)
ATTN: Shinya Kitamura PHONE NO :
330-2 SE DECISION MADE: 10-DEC-18
Nakano-Shi JP 383-8585 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LipiScan Dynamic Meibomian Imager
TearScience, Inc. 510(k) NO: K182506(Traditional)
ATTN: Christy Coleman PHONE NO : 919 4594815
5151 McCrimmon Pkwy. Ste. 250 SE DECISION MADE: 10-DEC-18
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Route 92 Medical Delivery Catheter
Route 92 Medical Inc. 510(k) NO: K182512(Traditional)
ATTN: Kathy Tansey PHONE NO : 408 3916536
1700 S. El Camino Real, Suite 206 SE DECISION MADE: 10-DEC-18
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StatStrip Xpress 2 Glucose Hospital Meter System
Nova Biomedical Corporation 510(k) NO: K182549(Dual Track)
ATTN: Khushboo Surendran PHONE NO : 781 8940800 1501
200 Prospect Street SE DECISION MADE: 13-DEC-18
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StatStrip Xpress Glucose Hospital Meter System
Nova Biomedical Corporation 510(k) NO: K182552(Dual Track)
ATTN: Khushboo Surendran PHONE NO : 781 8940800 1501
200 Prospect Street SE DECISION MADE: 13-DEC-18
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SureClip Repositionable Hemostasis Clip
Micro-Tech (Nanjing) CO., Ltd. 510(k) NO: K182556(Traditional)
ATTN: Becky Li PHONE NO : 86 25 58646378
NO. 10 Gaoke Third Road SE DECISION MADE: 14-DEC-18
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantib ND
Quantib BV 510(k) NO: K182564(Traditional)
ATTN: Floor van Leeuwen PHONE NO : 31 108411749
Westblaak 106 SE DECISION MADE: 27-DEC-18
Rotterdam NL 3012 KM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucent® XP
Spinal Elements Inc 510(k) NO: K182584(Traditional)
ATTN: Cheryl Allen PHONE NO : 760 6071840
3115 Melrose Dr., Suite 200 SE DECISION MADE: 10-DEC-18
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KET-1 Blood Ketone Monitoring System
Apex Biotechnology Corp. 510(k) NO: K182593(Traditional)
ATTN: Lisa Liu PHONE NO : 886 3 5641952
No. 7, Li-Hsin Road V, Hsinchu Sci SE DECISION MADE: 18-DEC-18
Hsinchu TW 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K182595(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
3366, Hanseo-ro, Nam-myeon, SE DECISION MADE: 18-DEC-18
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation 510(k) NO: K182601(Traditional)
ATTN: Paul Biggins PHONE NO : 81 287 266478
1385 Shimoishigami SE DECISION MADE: 14-DEC-18
Otawara JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
Medtronic 510(k) NO: K182610(Traditional)
ATTN: Kari Christianson PHONE NO : 763 5149529
7611 Northland Drive SE DECISION MADE: 19-DEC-18
Minneapolis MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIM - MRT Dosimetry
MIM Software Inc. 510(k) NO: K182624(Traditional)
ATTN: Lynn Hanigan PHONE NO : 216 4550600
25800 Science Park Drive - Suite 1 SE DECISION MADE: 18-DEC-18
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FiXcision
Agency for Medical Innovations Gmb 510(k) NO: K182664(Traditional)
ATTN: Martin Hohlrieder PHONE NO : 43 5522 905050
Im Letten 1 SE DECISION MADE: 07-DEC-18
Feldkirch AT 6800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid Reboot Compression Therapy System
Rapid Reboot Recovery Products, LL 510(k) NO: K182668(Traditional)
ATTN: David Johnson PHONE NO : 801 8997511
1396 W 200 S Bldg 2A SE DECISION MADE: 14-DEC-18
Lindon UT 84042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute
Prosidyan, Inc 510(k) NO: K182670(Traditional)
ATTN: Charanpreet S. Bagga PHONE NO : 908 5173666
41 Spring St, Suite 107 SE DECISION MADE: 20-DEC-18
New Providence NJ 07974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
Exciton Technologies, Inc. 510(k) NO: K182680(Special)
ATTN: Melanie Ussyk PHONE NO : 780 2485868
10230 Jasper avenue, suite 4147 SE DECISION MADE: 06-DEC-18
Edmonton CA T5J 4P6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AC5 Topical Gel
Arch Therapeutics, Inc. 510(k) NO: K182681(Traditional)
ATTN: Terrence W. Norchi PHONE NO : 617 4312316
235 Walnut Street, Suite 6 SE DECISION MADE: 14-DEC-18
Framingham MA 01702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoGold 100
Tissue Regeneration Technologies 510(k) NO: K182682(Traditional)
ATTN: John Warlick PHONE NO : 404 4026844
251 Heritage Walk SE DECISION MADE: 21-DEC-18
Woodstock GA 30188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKR 3000
KONICA MINOLTA, INC. 510(k) NO: K182688(Special)
ATTN: Tsutomu Fukui PHONE NO : 81 42 5898429
1 Sakura-machi SE DECISION MADE: 18-DEC-18
Hino-shi JP 191-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
GenMark Diagnostics, Incorporated 510(k) NO: K182690(Traditional)
ATTN: Beth Stofka PHONE NO : 760 5794778
5964 La Place Court SE DECISION MADE: 21-DEC-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
DiaSorin Inc. 510(k) NO: K182698(Traditional)
ATTN: John C. Walter PHONE NO : 651 4399710
1951 Northwestern Ave. SE DECISION MADE: 26-DEC-18
Stillwater MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wondfo T-Cup Multi-Drug Urine Test Cup
Guangzhou Wondfo Biotech Co., Ltd. 510(k) NO: K182701(Traditional)
ATTN: Bin Chen PHONE NO : 86 20 32296069
No.8 Lizhishan Road, Science City SE DECISION MADE: 03-DEC-18
Guangzhou CN 510641 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: One-Step Suprapubic Introducer
Cook Incorporated 510(k) NO: K182709(Traditional)
ATTN: Carly Powell PHONE NO : 812 3392235 104913
750 Daniels Way SE DECISION MADE: 26-DEC-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CelerityTM 10 STEAM Chemical Indicator
STERIS Corporation 510(k) NO: K182724(Traditional)
ATTN: Eileen McCafferty PHONE NO : 440 3927189
5960 Heisley Rd. SE DECISION MADE: 10-DEC-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OIC Suture Anchor System
The Orthopaedic Implant Company 510(k) NO: K182736(Traditional)
ATTN: Douglas Fulton PHONE NO : 775 6368281
770 Smithridge Dr. #400 SE DECISION MADE: 28-DEC-18
Reno NV 89502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EliA RF IgM Immunoassay
Phadia AB 510(k) NO: K182747(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 18-DEC-18
Uppsala SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4D View
GE Medical Systems Ultrasound and 510(k) NO: K182750(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W Innovation Drive SE DECISION MADE: 21-DEC-18
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Temperature Probe
Shenzhen Caremed Medical Technolog 510(k) NO: K182755(Traditional)
ATTN: Alan Xie PHONE NO : 86 755 36560977 889
East Side, 3/F, C Building, Kelunt SE DECISION MADE: 21-DEC-18
Dalang Office, Longhua District, S 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neocis Guidance System
Neocis Inc. 510(k) NO: K182776(Special)
ATTN: Thomas E. Claiborne PHONE NO : 631 7938945
555 NW 29th ST SE DECISION MADE: 21-DEC-18
Miami FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTS Professional Chemistry Kit
Polymer Technology Systems, Inc. d 510(k) NO: K182781(Traditional)
ATTN: Samuel Engelman PHONE NO : 317 8705610 1009
7736 Zionsville Road SE DECISION MADE: 21-DEC-18
Indianapolis IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Trauma Orthopedic Nail Implants
DePuy Synthes 510(k) NO: K182783(Traditional)
ATTN: Elizabeth Jacobs PHONE NO : 610 7195768
1301 Goshen Parkway SE DECISION MADE: 26-DEC-18
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardio-TriTest v6.5
Cardio-Phoenix Inc. 510(k) NO: K182790(Special)
ATTN: Marc Bisnaire PHONE NO : 416 5950795
44 Rosemead Close SE DECISION MADE: 14-DEC-18
Markham CA L3R 3Z3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LENSAR Laser System - fs 3D (LLS-fs 3D)
Lensar, Inc. 510(k) NO: K182795(Traditional)
ATTN: Keith Peck PHONE NO : 888 5756412
2800 Discovery Drive, Suite 100 SE DECISION MADE: 21-DEC-18
Orlando FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RCT800
RAY Co., Ltd 510(k) NO: K182805(Special)
ATTN: Changhwan Lee PHONE NO : 82 35 6051000
332-7, Samsung 1-ro SE DECISION MADE: 14-DEC-18
Hwaseong-si KR 18380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation 510(k) NO: K182809(Traditional)
ATTN: MaryBeth Carson PHONE NO : 609 3737461
311 Enterprise Drive SE DECISION MADE: 07-DEC-18
Plainsboro NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Distal Radius Plating System
Miami Device Solutions, LLC 510(k) NO: K182810(Special)
ATTN: Michelle Montesino PHONE NO : 786 4221400 106
7620 NW 25th Street, Unit 3 & 4 SE DECISION MADE: 10-DEC-18
Miami FL 33122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Cautery Electrode (SILICONE)
Medline Industries, Inc. 510(k) NO: K182812(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
Three Lakes Drive SE DECISION MADE: 12-DEC-18
Northfield IL 60093 510(k) STATEMENT
DEVICE: SabreLine and SabreGuard Laser Fibers
Coloplast Corp 510(k) NO: K182831(Traditional)
ATTN: Cori Ragan PHONE NO : 612 5975106
1601 West River Road North SE DECISION MADE: 10-DEC-18
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: minisono
Alpinion Medical Systems Co., Ltd. 510(k) NO: K182845(Traditional)
ATTN: Boyeon CHO PHONE NO : 82 70 74652104
5fl, i dong, 77, heungan-daero 81 SE DECISION MADE: 27-DEC-18
Anyang-si KR 14117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Integra Salto Total Ankle System
Ascension Orthopedics 510(k) NO: K182878(Special)
ATTN: Divya Savant PHONE NO : 609 9366968
11101 Metric Blvd. SE DECISION MADE: 18-DEC-18
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3880 MRI Patient Monitoring System
Iradimed Corporation 510(k) NO: K182900(Traditional)
ATTN: Francis X. Casey PHONE NO : 407 6778022
1025 Willa Springs Dr SE DECISION MADE: 14-DEC-18
Winter Springs FL 32708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precision1
Alcon Laboratories, Inc. 510(k) NO: K182902(Traditional)
ATTN: Alicia Plesnarski PHONE NO : 678 4153924
6201 South Freeway SE DECISION MADE: 11-DEC-18
Fort Worth TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UniPulse
Seaward Group 510(k) NO: K182905(Traditional)
ATTN: Jim Wallace PHONE NO : 440 191 5878724
15-18 Bracken Hill SE DECISION MADE: 14-DEC-18
Peterlee GB SR8 2SW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS Omadacycline 0.002-32 µg/mL
Liofilchem s. r. l. 510(k) NO: K182922(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 14-DEC-18
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: IntelliSpace Radiology
Philips Healthcare Informatics, In 510(k) NO: K182926(Third Party - Traditional)
ATTN: Paige Gridack PHONE NO : 321 3399144
4430 Rosewood Drive, Suite 200 SE DECISION MADE: 06-DEC-18
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Emission Computed Tomography System
Shanghai United Imaging Healthcare 510(k) NO: K182938(Traditional)
ATTN: Shumei Wang PHONE NO : 86 216707 68886776
No. 2258 Chengbei Rd., Jiading Ind SE DECISION MADE: 18-DEC-18
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invacare TDX SP2-HD with Captain's Seat
Invacare Corporation 510(k) NO: K182946(Special)
ATTN: Elijah Wreh PHONE NO : 440 3296840
One Invacare Way SE DECISION MADE: 11-DEC-18
Elyria OH 44035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Healix™ Compression Screw System
Nvision Biomedical Technologies, L 510(k) NO: K182949(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
4754 Shavano Oak, Suite 101 SE DECISION MADE: 04-DEC-18
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Salvo™ Spine System
Spine Wave, Inc. 510(k) NO: K182954(Traditional)
ATTN: Amy Noccioli PHONE NO : 203 9449494
3 Enterprise Drive, Suite 210 SE DECISION MADE: 12-DEC-18
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phoenix Atherectomy System
Volcano AtheroMed Inc. 510(k) NO: K182972(Special)
ATTN: Jean Chang PHONE NO : 650 3525255
1530 O'Brien Drive, Suite A SE DECISION MADE: 20-DEC-18
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURORA™ Screw System
MiRus, LLC 510(k) NO: K182989(Traditional)
ATTN: Jordan Bauman PHONE NO : 678 3246272
2150 Newmarket Parkway, Suite 108 SE DECISION MADE: 18-DEC-18
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: enlighten III Laser System
Cutera, Inc. 510(k) NO: K182997(Traditional)
ATTN: Julia Brown PHONE NO : 415 6575575
3240 Bayshore Blvd. SE DECISION MADE: 12-DEC-18
Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViperCath XC Peripheral Exchange Catheter
Cardiovascular Systems, Inc. 510(k) NO: K183000(Traditional)
ATTN: Erika Huffman PHONE NO : 651 2591608
1225 Old Highway 8 NW SE DECISION MADE: 29-DEC-18
St. Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EliA SmDP Immunoassay
Phadia AB 510(k) NO: K183007(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 24-DEC-18
Uppsala SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: vascuCAP
Elucid Bioimaging Inc. 510(k) NO: K183012(Traditional)
ATTN: Andrew Buckler PHONE NO : 978 4680508
225 Main Street SE DECISION MADE: 21-DEC-18
Wenham MA 01984 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSAIQ Oncology Information System
Elekta, Inc 510(k) NO: K183034(Traditional)
ATTN: Faiza Ahmed PHONE NO : 408 8308920
100 Mathilda Place 5th Floor SE DECISION MADE: 04-DEC-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dilator Sets
Cook Incorporated 510(k) NO: K183036(Traditional)
ATTN: David Lehr PHONE NO : 812 3352235 102309
750 Daniels Way SE DECISION MADE: 20-DEC-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monaco RTP System
Elekta, Inc 510(k) NO: K183037(Traditional)
ATTN: Kathryn Stinson PHONE NO : 314 9930003
13723 Riverport Drive, Suite 100 SE DECISION MADE: 04-DEC-18
Maryland Heights MO 63043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zenition 70
Philips Medical Systems Nederland 510(k) NO: K183040(Abbreviated)
ATTN: Sumit Kumar PHONE NO : 91 702 8039288
Veenpluis 4-6 SE DECISION MADE: 06-DEC-18
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3nethra neo
Forus Health Pvt. Ltd. 510(k) NO: K183059(Traditional)
ATTN: Shruti Kashinath PHONE NO : 91 80 41624041
#86/2, Ground Floor, Dvg Smaraka B SE DECISION MADE: 21-DEC-18
Bengalura IN 560019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coolrail Linear Pen
AtriCure, Inc. 510(k) NO: K183065(Special)
ATTN: Caitlin Wunderlin PHONE NO : 513 7554100
7555 Innovation Way SE DECISION MADE: 04-DEC-18
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Glove Powder Free White
Haining Medical Products Co., Ltd. 510(k) NO: K183068(Traditional)
ATTN: Zhiming Yao PHONE NO : 86 315 4167693
West of Dianchang Road, Luannan Co SE DECISION MADE: 21-DEC-18
Tangshan CN 063500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NobelZygoma 0°
Nobel Biocare AB 510(k) NO: K183069(Special)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
Box 5190, SE-402 26, Vastra Hamnga SE DECISION MADE: 04-DEC-18
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mega Plus Spine System
BK Meditech Co., Ltd 510(k) NO: K183080(Special)
ATTN: Meredith Lee May PHONE NO : 719 2916874
58, Eunhaengnamu-ro Yanggam-myeon SE DECISION MADE: 10-DEC-18
Hwaseong-si KR 18633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senhance Surgical System
TransEnterix, Inc. 510(k) NO: K183098(Special)
ATTN: Michele Jans PHONE NO : 919 7658420
635 Davis Drive, Suite 300 SE DECISION MADE: 06-DEC-18
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
Leica Biosystems Newcastle Limited 510(k) NO: K183100(Special)
ATTN: Jeremy Allen PHONE NO : 0044 191 2154216
Balliol Business Park West, Benton SE DECISION MADE: 07-DEC-18
Newcastle Upon Tyne GB NE12 8EW 510(k) STATEMENT
DEVICE: Zenition 50
Philips Medical Systems Nederland 510(k) NO: K183101(Abbreviated)
ATTN: Sumit Kumar PHONE NO : 91 70 28039288
Veenpluis 4-6 SE DECISION MADE: 31-DEC-18
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
Leica Biosystems Newcastle Limited 510(k) NO: K183102(Special)
ATTN: Jeremy Allen PHONE NO : 0044 191 2154216
Balliol Business Park West, Benton SE DECISION MADE: 07-DEC-18
Newcastle Upon Tyne GB NE12 8EW 510(k) STATEMENT
DEVICE: Intuitive Surgical Vessel Sealer Extend
Intuitive Surgical, Inc. 510(k) NO: K183107(Traditional)
ATTN: Kunal Gunjal PHONE NO : 408 5238017
1266 Kifer Road SE DECISION MADE: 11-DEC-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Contour 24
Quality Electrodynamics, LLC 510(k) NO: K183111(Traditional)
ATTN: Eric Yeh PHONE NO : 440 4842940
6655 Beta Drive Suite 100 SE DECISION MADE: 07-DEC-18
Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS Levofloxacin 0.002 - 32 µg/mL
Liofilchem s. r. l. 510(k) NO: K183115(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 20-DEC-18
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: Unity Network ID
GE Healthcare 510(k) NO: K183116(Special)
ATTN: Brandon O'Shea PHONE NO : 414 3233147
8200 West Tower Ave. SE DECISION MADE: 06-DEC-18
Milwaukee WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: microTargeting Guideline 4000 5.0 System
FHC, Inc. 510(k) NO: K183123(Special)
ATTN: Kelly Moeykens PHONE NO : 207 6665651
1201 Main Street SE DECISION MADE: 20-DEC-18
Bowdoin ME 04287 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
Abbott 510(k) NO: K183128(Special)
ATTN: Cody Johnson PHONE NO : 651 7564217
One St. Jude Medical Drive SE DECISION MADE: 12-DEC-18
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IlluminOss Photodynamic Bone Stabilization System
IlluminOss Medical, Inc. 510(k) NO: K183145(Special)
ATTN: Robert Rabiner PHONE NO : 401 7140008
993 Waterman Avenue SE DECISION MADE: 13-DEC-18
East Providence RI 02914 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affixus Hip Fracture Nail
Biomet Inc. 510(k) NO: K183162(Special)
ATTN: Dhaval Saraiya PHONE NO : 305 2696386
56 East Bell Drive SE DECISION MADE: 14-DEC-18
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OpenLoc-L Spinal Fixation System
L&K Biomed Co., Ltd. 510(k) NO: K183168(Special)
ATTN: Jihyeon Seo PHONE NO : 82 2 67171983
#201, 202 16-25, Dongbaekjungang-r SE DECISION MADE: 11-DEC-18
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse 2.0, Pulse Pro 2.0
NormaTec Industries, LP 510(k) NO: K183169(Third Party - Traditional)
ATTN: Albert G. Sanford PHONE NO : 800 3350960
480 Pleasant St, Suite A200 SE DECISION MADE: 27-DEC-18
Watertown MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Riptide Aspiration System (Riptide Large Bore Aspiration System)
Micro Therapeutics, Inc. d/b/a ev3 510(k) NO: K183185(Special)
ATTN: Nancy Drew PHONE NO : 949 2979563
9775 Toledo Way SE DECISION MADE: 18-DEC-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6420 Ultrasound System
Esaote, S.p.A. 510(k) NO: K183191(Special)
ATTN: Massimo Polignano PHONE NO : 39 055 4229402
Via enrico Melen 77 SE DECISION MADE: 04-DEC-18
Genova IT 16152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowTriever Retrieval/Aspiration System
Inari Medical 510(k) NO: K183198(Special)
ATTN: Eben Gordan PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 17-DEC-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nexus DR Digital X-ray Imaging System with stitching
Varex Imaging Corporation 510(k) NO: K183212(Special)
ATTN: Michael Van Ryn PHONE NO : 315 2346800
121 Metropolitan Drive SE DECISION MADE: 07-DEC-18
Liverpool NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
DiaSorin Molecular LLC 510(k) NO: K183223(Special)
ATTN: Sharon Young PHONE NO : 562 2406680
11331 Valley View Street SE DECISION MADE: 19-DEC-18
Cypress CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreLink F3D™ Lateral System
Corelink, LLC 510(k) NO: K183239(Special)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Blvd. SE DECISION MADE: 19-DEC-18
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ValPro 2 Plus, VaPro 2 Plus Pocket
Hollister Incorporated 510(k) NO: K183253(Special)
ATTN: Michelle Schiltz-Taing PHONE NO : 847 6802122
2000 Hollister Drive SE DECISION MADE: 18-DEC-18
Libertyville IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Selectra Catheters, Selectra Accessory Kit
Biotronik, Inc. 510(k) NO: K183265(Special)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 13-DEC-18
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System
Osprey Medical, Inc. 510(k) NO: K183267(Special)
ATTN: Melanie Hess PHONE NO : 952 9558252
5600 Rowland Rd, Suite 250 SE DECISION MADE: 20-DEC-18
Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 17HK701G-W
LG Electronics Inc. 510(k) NO: K183286(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
222, LG-Ro SE DECISION MADE: 07-DEC-18
Jinwi-Myeon Pyeongtaek-Si KR 1770 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magma Spark Pro (Magma Spark Plus, Alpha)
Formatk Systems Ltd. 510(k) NO: K183307(Special)
ATTN: Amit Goren PHONE NO : 972 4 8571848
3 Hayozma St. SE DECISION MADE: 11-DEC-18
Tirat Hacarmel IL 3903203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Rx 2.0, Pulse Pro Rx 2.0
NormaTec Industries, LP 510(k) NO: K183328(Third Party - Traditional)
ATTN: Albert G. Sanford PHONE NO : 800 3350960
480 Pleasant St, Suite A200 SE DECISION MADE: 21-DEC-18
Watertown MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Reusable Silicone Cover CPRmeter 2
Laerdal Medical AS 510(k) NO: K183348(Special)
ATTN: Mari Kaada PHONE NO : 47 51 511700
Tanke Svilandsgate 30 SE DECISION MADE: 17-DEC-18
Stavanger NO 2007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COR12 ECG
Corscience GmbH & Co. 510(k) NO: K183369(Third Party - Traditional)
ATTN: Karlheinz Trost PHONE NO : 49 9131 977986 518
Hartmannstrasse 65 SE DECISION MADE: 28-DEC-18
Erlangen DE D-91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ANAX™ OCT Spinal System
U & I Corporation 510(k) NO: K183383(Special)
ATTN: Young Eun Lee PHONE NO : 82 31 8606927
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 12-DEC-18
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
