Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 47
- Latest Decision
- 2017-05-19
Clearances · page 18 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K163644 | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation | OMA | Class II | 2017-05-19 |
| K171152 | Stryker Universal Neuro III System AXS Screw | Stryker | HBW | Class II | 2017-05-19 |
| K162542 | OsteoMed PINNACLE Driver | Osteomed | HBE | Class II | 2017-05-19 |
| K170018 | StealthStationTM S8 ENT Software | Medtronic Navigation, Inc. | PGW | Class II | 2017-05-19 |
| K170462 | KARL STORZ ShuntScope | KARL STORZ Endoscopy-America, Inc. | GWG | Class II | 2017-05-16 |
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools | Medtronic Powered Surgical Solutions | HBC | Class II | 2017-05-15 |
| K162392 | Avazzia | Avazzia, Inc. | NUH | Class II | 2017-05-12 |
| K170581 | Mako Total Knee Application | Mako Surgical Corp. | OLO | Class II | 2017-05-11 |
| K170584 | Mako Partial Knee Application | Mako Surgical Corp. | OLO | Class II | 2017-05-11 |
| K170205 | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 | Shenzhen Kentro Medical Electronics Co., Ltd. | NUH | Class II | 2017-05-11 |
| K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | OMC | Class II | 2017-05-08 |
| K170744 | Adhesive Electrodes | Reno Medical , Ltd. | GXY | Class II | 2017-05-08 |
| K163315 | Internal Distraction - Sterile | KLS Martin L.P. | PBJ | Class II | 2017-05-05 |
| K170977 | SURESHOT Distal Targeting System V4.0 Trauma Interface | Smith & Nephew, Inc. | OLO | Class II | 2017-05-03 |
| K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | Stimwave Technologies Incorporated | GZB | Class II | 2017-05-02 |
| K170360 | NAVIO | Blue Belt Technologies, Inc. | OLO | Class II | 2017-05-02 |
| K170114 | MagVita TMS Therapy - w/MagPro R20 | Tonica Elektronik A/S | OBP | Class II | 2017-05-01 |
| K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | OLO | Class II | 2017-05-01 |
| K170145 | Digital TENS Unit | Shenzhen Eapply Technology Co., Ltd. | NUH | Class II | 2017-04-29 |
| K170926 | BrainPulse 1100 | Jan Medical, Inc. | POP | Class II | 2017-04-28 |
| K162460 | WAVi Headset and WAVi eSoc Single Use Electrode Contacts | Wavi Co. | GXY | Class II | 2017-04-28 |
| K170280 | Smith & Nephew SURESHOT Distal Targeting System V4.0 | Smith & Nephew, Inc. | OLO | Class II | 2017-04-28 |
| K163149 | VisualEyes | Interacoustics A/S | GWN | Class II | 2017-04-26 |
| K170132 | MyoCycle Home, MyoCycle Pro | Myolyn, LLC | GZI | Class II | 2017-04-25 |
| K162237 | XO1 Knee Balancing System | Xpandortho, Inc. | ONN | Class II | 2017-04-25 |
| K162655 | StealthConnect Remote Viewing, Planning and Collaboration System | Medtronic Navigation, Inc. | HAW | Class II | 2017-04-21 |
| K170593 | Mako Total Hip Application | Mako Surgical Corp. | OLO | Class II | 2017-04-18 |
| K162108 | Pressio 2 ICP Monitoring System | Sophysa SA | GWM | Class II | 2017-04-17 |
| K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Jkh Health Co., Ltd. | NUH | Class II | 2017-04-14 |
| K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2017-04-14 |
| K162891 | Complete Control System | Coapt, LLC | GXY | Class II | 2017-04-14 |
| DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | Electrocore, LLC | PKR | Class II | 2017-04-14 |
| K163461 | Coolief* Cooled RF Probe | Halyard Health, Inc. | GXI | Class II | 2017-04-13 |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | GZL | Class II | 2017-04-12 |
| K163547 | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 | Neurovirtual USA, Inc. | GXY | Class II | 2017-04-11 |
| K163617 | REMbrandt | Embla Systems | OLZ | Class II | 2017-04-11 |
| K170677 | Neurovision Nerve Locator Monitor (Nerveana), EMGView Software | Neurovision Medical Product, Inc. | GWF | Class II | 2017-04-05 |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | OLO | Class II | 2017-04-05 |
| K163221 | Mazor X | Mazor Robotics , Ltd. | OLO | Class II | 2017-04-04 |
| K162873 | MEP Monitor | Tonica Elektronik A/S | GWF | Class II | 2017-03-31 |
| K162627 | EnsoSleep | Ensodata, Inc. | OLZ | Class II | 2017-03-31 |
| K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | Medtronic Navigation, Inc. | HAW | Class II | 2017-03-31 |
| K162999 | V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System | MicroVention, Inc. | HCG | Class II | 2017-03-29 |
| K163565 | MR8 Drill System | Medtronic Powered Surgical Solutions | HBC | Class II | 2017-03-28 |
| K161731 | Cleveland Multiport Ventricular Catheter Set | Parker Hannifin Corp. | HCA | Class II | 2017-03-27 |
| K161835 | iovera system | Myoscience, Inc. | GXH | Class II | 2017-03-24 |
| K161680 | MEDICON Spinal Spreading Systems | Medicon EG | GZT | Class II | 2017-03-24 |
| K163558 | Synapsys Ulmer Video Nystagmograph | Synapsys SA | GWN | Class II | 2017-03-23 |
| K162037 | Eclipse with VEMP | Interacoustics A/S | GWJ | Class II | 2017-03-23 |
| K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories | Medtronic Powered Surgical Solutions | HBB | Class II | 2017-03-23 |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | Tedan Surgical Innovations, LLC | GZT | Class II | 2017-03-20 |
| K162880 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | GWG | Class II | 2017-03-16 |
| K162921 | Navigated Instrument System | Orthofix, Inc. | OLO | Class II | 2017-03-13 |
| K162935 | Rapid2 Therapy System | Magstim Company, Ltd. | OBP | Class II | 2017-03-10 |
| K170430 | TSolution One Surgical System Model 210 | THINK Surgical, Inc. | OLO | Class II | 2017-03-06 |
| K162364 | Intellijoint HIP Generation 2A System | Intellijoint Surgical, Inc. | OLO | Class II | 2017-03-02 |
| K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | GWF | Class II | 2017-03-02 |
| K163379 | KneeAlign 2 System | Orthalign, Inc. | OLO | Class II | 2017-03-02 |
| K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System | Aesculap, Inc. | JXG | Class II | 2017-02-27 |
| K161484 | ZIIP Device | Ziip,Llc | NFO | Class II | 2017-02-24 |
| K163322 | TZ SKULL PIN Adult | Tz Medical, Inc. | HBL | Class II | 2017-02-23 |
| K162937 | Stryker OrthoMap Versatile Hip System | Stryker Corporation | OLO | Class II | 2017-02-23 |
| K170209 | ImPACT | Impact Applications, Inc. | POM | Class II | 2017-02-23 |
| K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker | Stryker Corporation | HAW | Class II | 2017-02-22 |
| DEN140033 | Companion | Lgch, Inc. | POS | Class II | 2017-02-16 |
| K163416 | Fiagon Navigation PointerTube Straight and PointerTube Keat | Fiagon GmbH | PGW | Class II | 2017-02-16 |
| K161491 | Scopis Hybrid Navigation System EM | Scopis GmbH | PGW | Class II | 2017-02-09 |
| K162479 | Smart Pain Reliever, Model LT5019 | Shenzhen Dongdixin Technology Co., Ltd. | NUH | Class II | 2017-02-08 |
| K161715 | EndyGel | Endymed Medical, Ltd. | GYB | Class II | 2017-02-07 |
| K162683 | RehaStim 2 | Hasomed GmbH | GZI | Class II | 2017-02-03 |
| K162106 | Micro-current Wrinkle Reduction Facial service, model EP-400 | Li-Tek Electronic Technology Corporation | NFO | Class II | 2017-02-03 |
| K162407 | L300 Go System | Bioness, Inc. | GZI | Class II | 2017-01-27 |
| K162962 | OrthAlign Plus System | Orthalign, Inc. | OLO | Class II | 2017-01-23 |
| K161650 | Polysmith Sleep System, Model NTI7593 | Neurotronics, Inc. | OLV | Class II | 2017-01-19 |
| K161090 | Cranial PSI | Ossdsign AB | GXN | Class II | 2017-01-19 |
| K153587 | Taps for Resorbable Screws | Synthes (USA) Products, LLC | HBG | Class II | 2017-01-18 |
| K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | GZJ | Class II | 2017-01-18 |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A | Well-Life Healthcare Limited | GZJ | Class II | 2017-01-17 |
| K162864 | OsteoVation Impact | Skeletal Kinetics, LLC | GXP | Class II | 2017-01-13 |
| K161328 | Cantab Mobile | Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. | PKQ | Class II | 2017-01-13 |
| K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | HBG | Class II | 2017-01-12 |
| K163457 | NeuraGen 3D Nerve Guide Matrix | Integra LifeSciences Corporation | JXI | Class II | 2017-01-06 |
| K163456 | DuraGen Secure Dural Regeneration Matrix | Integra LifeSciences Corporation | GXQ | Class II | 2017-01-06 |
| K162704 | Axium Prime Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | HCG | Class II | 2017-01-03 |
| K162604 | Cranial Reducing Tubes | Medtronic Navigation, Inc. | HAW | Class II | 2016-12-30 |
| K161654 | NuFACE Gel Primer | Carol Cole Company | GYB | Class II | 2016-12-30 |
| K162375 | Envision 3D: Image Guidance System | 7D Surgical, Inc. | OLO | Class II | 2016-12-29 |
| K160309 | Neurosoft TMS | Teleemg, LLC | OBP | Class II | 2016-12-22 |
| K161566 | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | GXZ | Class II | 2016-12-21 |
| K162630 | CP Relief Wand-OTC | Mid-America Medical Innovations, LLC | NUH | Class II | 2016-12-20 |
| K160707 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | GXN | Class II | 2016-12-17 |
| K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | Stimwave Technologies Incorporated | GZB | Class II | 2016-12-16 |
| K163236 | COOLIEF Cooled Radiofrequency Kit | Halyard Health, Inc. | GXI | Class II | 2016-12-16 |
| K163163 | XLTEK EMU40EX EEG Headbox | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | GWQ | Class II | 2016-12-14 |
| K161821 | Stryker Universal Mesh | Stryker | GWO | Class II | 2016-12-08 |
| K160811 | CRW STEREOTACTIC SYSTEM | Integra LifeSciences Corporation | HAW | Class II | 2016-12-06 |
| K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A | Well-Life Healthcare Limited | NUH | Class II | 2016-12-05 |
| K161704 | Phasor Drill | Biotex, Inc. | HBE | Class II | 2016-12-01 |
| K162176 | Fiagon Navigation System | Fiagon GmbH | PGW | Class II | 2016-12-01 |
| K162140 | RemLogic | Embla Systems | OLZ | Class II | 2016-12-01 |
6,130 clearances in the Neurology panel. Data: openFDA.