meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
46
Latest Decision
2016-11-21

Clearances · page 19 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K160508 Electronic Pulse Stimulator Beijing Choice Electronic Technololgy Co., Ltd. NUH Class II 2016-11-21
K162539 Solitaire 2 Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular POL Class II 2016-11-10
K161027 Cadwell AmpliScan Cadwell Industries, Inc. OMA Class II 2016-11-08
K162595 Trex_HD Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) GWQ Class II 2016-11-04
K161370 Durepair Dura Regeneration Matrix Medtronic Neurosurgery GXQ Class II 2016-11-02
K162741 AxoGuard Nerve Connector Cook Biotech Incorporated JXI Class II 2016-10-31
K161282 FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W Medico Electrodes International , Ltd. GXY Class II 2016-10-30
K162437 Codman EDS3 CSF External Drainage System Codman & Shurtleff, Inc. JXG Class II 2016-10-28
K161605 Smart External Drain (SED) System Aqueduct Critical Care, Inc. JXG Class II 2016-10-27
K161701 CARTO ENT System Biosense Webster PGW Class II 2016-10-24
K161697 Acclarent NavWire Sinus Navigation Guidewire Acclarent, Inc. PGW Class II 2016-10-24
K161555 KARL STORZ NAV1 Electromagnetic Navigation System Karl Storz Endoscopy America, Inc. PGW Class II 2016-10-21
K161010 HICP200 Patient/Monitor Interconnect Cable Innerspace Neuro Solutions, Inc. GWM Class II 2016-10-20
K160081 TENS Electrodes Cathay Manufacturing Corp. GXY Class II 2016-10-19
K161537 OTC TENS Device, Model PTS-IV Counter Scientific Development (Gz), Ltd. NUH Class II 2016-10-13
K162341 Stryker OrthoMap Precision Knee system Stryker Leibinger GmbH & Co KG OLO Class II 2016-10-12
K160246 SimulCare II(TM) Xanacare Technologies, LLC GZJ Class II 2016-10-06
K151995 Painmaster MCT Patch Newmark, Inc. NUH Class II 2016-10-05
K161446 Biopor Porous Polyethylene Implants Ceremed , Inc. GWO Class II 2016-09-27
K151285 VSP Cranial System 3D Systems, Inc. PPT Class II 2016-09-23
K161068 Ahead 300 Brainscope Company, Inc. PIW Class II 2016-09-22
K161992 Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems Integra LifeSciences Corporation JXG Class II 2016-09-22
K161717 Personal Kinetigraph (PKG) System Gkc Manufacturing Pty, Ltd. GYD Class II 2016-09-20
K161940 Guidewire 0.6 Single Use Fiagon GmbH PGW Class II 2016-09-18
K161112 KARL STORZ Flexible Video-Neuro-Endoscope System KARL STORZ Endoscopy-America, Inc. GWG Class II 2016-09-17
K160255 HBOTC Muscle and Nerve Stimulator Hb Medical, Inc. NUH Class II 2016-09-15
K162195 TSolution One Cup1 Surgical System THINK Surgical, Inc. OLO Class II 2016-09-14
K153660 StealthStation System with Cranial Software Medtronic Navigation, Inc. HAW Class II 2016-09-14
K161519 NeuroStar TMS Therapy System Neuronetics, Inc. OBP Class II 2016-09-11
K161004 Self-retaining Retractor Fetzer Medical GmbH & Co. KG GZT Class II 2016-09-09
K161744 Symmetry Sharp Kerrison Rongeur Symmetry Surgical, Inc. HAE Class II 2016-09-07
DEN150049 Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm Concentric Medical, Inc. POL Class II 2016-09-02
K161367 HydroCoil Embolic System (HES) MicroVention, Inc. HCG Class II 2016-08-31
K161452 MicroPlex Coil System (MCS) - HyperSoft 3D MicroVention, Inc. HCG Class II 2016-08-31
K152642 LCCS Disposable RF Electrode, LCCS Reusable RF Electrode Lccs Products Limited GXI Class II 2016-08-26
K160600 Freedom Spinal Cord Stimulator System Stimwave Technologies Incorporated GZB Class II 2016-08-26
K161663 sTMS mini Eneura, Inc. OKP Class II 2016-08-23
DEN150037 ImPACT Computerized Neurocognitive Concussion Management Aid Impact Applications, Inc. POM Class II 2016-08-22
K153347 Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit Codman & Shurtleff, Inc. GWM Class II 2016-08-19
K160138 Adhesive Electrodes Gmdasz Manufacturing Co., Ltd. GXY Class II 2016-08-11
K161278 Cerafix Dura Substitute Acera Surgical, Inc. GXQ Class II 2016-08-08
K153243 Fehling-Punches Fehling Instruments GmbH & Co. KG HAE Class II 2016-08-04
DEN140040 Nautilus BrainPulse 1000 Jan Medical, Inc. POP Class II 2016-08-01
K160893 HANAROCare ReJu M.I.Tech Co., Ltd. NUH Class II 2016-07-27
K160385 Precision Screw Cryptych Pty, Ltd. OLO Class II 2016-07-27
K161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs Spr Therapeutics, LLC NHI Class II 2016-07-23
K152960 ELAN 4 Motor System Aesculap, Inc. HBC Class II 2016-07-22
K161138 St. Louis Band Orthomerica Products, Inc. OAN Class II 2016-07-20
DEN150004 EPIC ClearView System Epic Research & Diagnostics, Inc. PNA Class I 2016-07-15
K151790 PMT Platinum Depthalon Depth Electrode Pmt Corporation GZL Class II 2016-07-14
K152764 EXACTECH GPS Blue Ortho HAW Class II 2016-07-13
K153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set Relievant Medsystems GXI Class II 2016-07-09
K153700 Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments Aesculap Implant Systems, LLC OLO Class II 2016-07-08
K153240 Styrker OrthoMap Express Knee System Stryker Corporate OLO Class II 2016-07-07
K160523 BrightMatter Guide with BrightMatter Pointer Synaptive Medical, Inc. HAW Class II 2016-06-24
K153353 SANDMAN ELITE Embla Systems OLZ Class II 2016-06-23
K152967 NERBRIDGE Toyobo Co., Ltd. JXI Class II 2016-06-22
K161429 Target Detachable Coils Stryker Neurovascular HCG Class II 2016-06-22
K152734 Kerrison Rongeurs Vitalitec Medizintechnik GmbH HAE Class II 2016-06-18
K160739 Cranial COVER Neos Surgery S.L GXR Class II 2016-06-12
K160703 NeuroStar TMS Therapy System Neuronetics, Inc. OBP Class II 2016-06-10
K152342 Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover St Jude Medical GXR Class II 2016-06-09
K152301 Background Pattern Classification [BPc(TM)] Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) OMA Class II 2016-06-03
K160115 Heat Pain Pro Omron Healthcare, Inc. NUH Class II 2016-06-03
K153704 Strive Djo, LLC GZJ Class II 2016-06-03
K160713 Stealth-Midas System Medtronic Powered Surgical Solutions OLO Class II 2016-05-26
K151784 ActTrust Condor Instruments Ltda. - Epp LEL Class II 2016-05-25
K160052 CUR Model 1 Thimble Bioelectronics, Inc. NUH Class II 2016-05-20
K153658 Target Detachable Coils Stryker Neurovascular HCG Class II 2016-05-19
K160537 Navio Blue Belt Technologies, Inc. OLO Class II 2016-05-19
K160280 MagPro R20 Tonica Elektronik A/S GWF Class II 2016-05-16
K153396 Aesculap OrthoPilot Next Generation Aesculap Implant Systems, LLC OLO Class II 2016-05-16
DEN140032 Cereve Sleep System Cereve, Inc. PLU Class II 2016-05-13
K153520 Electronic Pulse Stimulator Jkh Health Co., Ltd. NUH Class II 2016-05-05
K153603 Alphatec Navigation Instruments Alphatec Spine, Inc. OLO Class II 2016-04-29
K152727 ISEN-Goggles Isen Tech & Trading Company, Ltd. GWN Class II 2016-04-26
K160832 Penumbra Smart Coil Penumbra, Inc. HCG Class II 2016-04-20
K150372 VERASENSE Knee System Orthosensor, Inc. ONN Class II 2016-04-15
K160223 VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter Cook Incorporated NHC Class II 2016-04-08
K152184 MagView BIOMAGNETOMETER SYSTEM Tristan Technologies, Inc. OLY Class II 2016-04-08
K152700 StrataMR Valves and Shunts Medtronic Neurosurgery JXG Class II 2016-04-07
K153555 EM ENT Navigated Suctions Medtronic Navigation, Inc. PGW Class II 2016-04-07
K153163 ReGrasp Rehabtronics, Inc. GZI Class II 2016-04-07
K151156 Fiagon Navigation System Fiagon GmbH HAW Class II 2016-04-01
K153281 BrightMatter Guide with Surface Trace Registration Synaptive Medical, Inc. HAW Class II 2016-03-30
K160129 MRII Cranial Drill and Accessories Mri Interventions, Inc. HBG Class II 2016-03-26
K152199 RejuvatoneMD Trophy Skin, Inc. NFO Class II 2016-03-23
K160479 PointerShell Universal, PointerShell LS Fiagon GmbH PGW Class II 2016-03-23
K153019 Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes Bio Protech, Inc. GXY Class II 2016-03-21
K152699 Apollo System Penumbra, Inc. GWG Class II 2016-03-17
K160434 ClearPoint System Mri Interventions, Inc. HAW Class II 2016-03-17
K153519 DReal Carevature Medical, Ltd. HBE Class II 2016-03-16
K153613 Cerafix Dura Substitute Acera Surgical, Inc. GXQ Class II 2016-03-16
K153412 Sleep Profiler Advanced Brain Monitoring, Inc. OLZ Class II 2016-03-14
K153041 Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling Integra LifeSciences Corporation JXG Class II 2016-03-14
K152178 StimQ Peripheral Nerve Stimulator (PNS) System Stimq, LLC GZF Class II 2016-03-11
K160369 GuideWire Fiagon GmbH PGW Class II 2016-03-10
K153248 PEEK Customized Cranial Implant Stryker GWO Class II 2016-03-10
K152815 Mailuokang Self-adhesive Electrode Shenzhen Mailuokang Technology Co., Ltd. GXY Class II 2016-03-08
K152897 Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory Integra LifeSciences Corporation JXG Class II 2016-03-04

6,130 clearances in the Neurology panel. Data: openFDA.