Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 44
- Latest Decision
- 2021-08-31
Clearances · page 11 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K210448 | Adhesive Electrode | Shaoxing Yingtuo Healthcare Co., Ltd. | GXY | Class II | 2021-08-31 |
| K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | GXY | Class II | 2021-08-30 |
| K210502 | Trevo NXT ProVue Retriever | Stryker Neurovascular | POL | Class II | 2021-08-27 |
| K202781 | Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. | GZF | Class II | 2021-08-27 |
| K203251 | SOLOPASS System | Intravent Medical Partners, LP | HAW | Class II | 2021-08-27 |
| K212023 | Virage Navigation System | Zimmer Biomet Spine, Inc. | OLO | Class II | 2021-08-27 |
| K211616 | ExcelsiusHub | Globus Medical, Inc. | OLO | Class II | 2021-08-25 |
| K203739 | ELAN 4 Electro Motor System | Aesculap, Inc. | HBE | Class II | 2021-08-24 |
| DEN210003 | SureTune4 Software | Medtronic Neuromodulation | QQC | Class II | 2021-08-23 |
| K202836 | GX Navigation Instrument System | Life Spine, Inc. | OLO | Class II | 2021-08-19 |
| K211376 | STARband | Orthomerica Products, Inc. | OAN | Class II | 2021-08-17 |
| K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | Brainsway , Ltd. | OBP | Class II | 2021-08-17 |
| K202636 | Metallic Fabric Electrodes | Guangzhou Xinbo Electronic Co., Ltd. | GXY | Class II | 2021-08-16 |
| K192823 | MEGA-TMS | Soterix Medical, Inc. | GWF | Class II | 2021-08-13 |
| K212007 | VERTICALE Navigation Instruments | Silony Medical GmbH | OLO | Class II | 2021-08-12 |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | Stryker | GWG | Class II | 2021-08-06 |
| K202621 | NeuroSENSE Monitoring System, Model NS-901 | Neurowave Systems, Inc. | OLW | Class II | 2021-08-05 |
| K212106 | Relivion | Neurolief , Ltd. | PCC | Class II | 2021-08-02 |
| K211380 | Elexir | Nu Eyne Co., Ltd. | PCC | Class II | 2021-07-30 |
| K210574 | NuVasive Pulse System | Nu Vasive, Incorporated | OLO | Class II | 2021-07-29 |
| K211839 | Electrode Market Disposable Surface Electrodes | Electrode Market Co., Ltd. | GXY | Class II | 2021-07-28 |
| K211643 | Vision Monitor - MonpackONE | Metrovision | GWE | Class II | 2021-07-26 |
| K211188 | xvision Spine system (XVS) | Augmedics, Ltd. | SBF | Class II | 2021-07-19 |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | Fiagon GmbH | PGW | Class II | 2021-07-19 |
| K203115 | ARVIS Surgical Navigation System | Insight Medical Systems, Inc. | OLO | Class II | 2021-07-14 |
| K203158 | BioWave BioWraps | Biowave Corporation | GXY | Class II | 2021-07-08 |
| K211442 | StealthStation Spinous Process Clamps | Medtronic Navigation | OLO | Class II | 2021-07-08 |
| K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | HCG | Class II | 2021-07-07 |
| K210199 | RICOH MEG | Ricoh Company, Ltd. | OLX | Class II | 2021-07-02 |
| K210377 | Stryker iBur hubs and cutting accessories | Stryker Corporation | HBE | Class II | 2021-06-30 |
| K211596 | CD Horizon Spinal System | Medtronic | OLO | Class II | 2021-06-23 |
| K210457 | 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key | 7D Surgical, Inc. | OLO | Class II | 2021-06-21 |
| K202893 | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | GZJ | Class II | 2021-06-18 |
| K210700 | NaviNetics D1 Stereotactic System | Navinetics, Inc. | HAW | Class II | 2021-06-17 |
| K210364 | Migraine Tens Digital Pain Reliever | Shenzhen Dongdixin Technology Co., Ltd. | PCC | Class II | 2021-06-17 |
| K210034 | EnsoSleep | Ensodata, Inc. | OLZ | Class II | 2021-06-16 |
| K210756 | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H | Shenzhen Osto Technology Company Limited | NUH | Class II | 2021-06-11 |
| K210021 | Axon Therapy | Neuralace Medical, Inc. | QPL | Class II | 2021-06-11 |
| K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2021-06-09 |
| K193383 | SnugKap | Headstart, Ltd. | MVA | Class II | 2021-06-07 |
| K200694 | Perfect EMS | Tenscare, Ltd. | NUH | Class II | 2021-06-04 |
| K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | Mecta Corporation | JXL | Class II | 2021-06-04 |
| DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | QPF | Class II | 2021-06-02 |
| K200942 | Well-Life Garment Electrodes (GM Series) | Well-Life Healthcare Limited | GXY | Class II | 2021-06-01 |
| K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems | Medos International SARL | HCG | Class II | 2021-05-28 |
| K190703 | Neuro-IOM system with Neuro-IOM.NET software | Neurosoft , Ltd. | GWF | Class II | 2021-05-22 |
| K203331 | Quick-20m | Cgx, LLC | GWL | Class II | 2021-05-20 |
| K201569 | CUVIS-spine | Curexo, Inc. | OLO | Class II | 2021-05-19 |
| K202866 | TENS & EMS Device | Shenzhen Jian Feng Electronic Technology Co., Ltd. | NUH | Class II | 2021-05-19 |
| K210153 | NextAR RSA Platform | Medacta International S.A. | SBF | Class II | 2021-05-12 |
| K200768 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | HAE | Class II | 2021-05-04 |
| K210993 | CereLink ICP Monitor | Integra Lifesciences Production Corporation | GWM | Class II | 2021-04-30 |
| K203098 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | OAN | Class II | 2021-04-27 |
| K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT Device | Avazzia, Inc. | NFO | Class II | 2021-04-27 |
| DEN200046 | Neurolutions Upper Extremity Rehabilitation System | Neurolutions, Inc. | QOL | Class II | 2021-04-23 |
| K203735 | Brainsway Deep TMS System | Brainsway , Ltd. | OBP | Class II | 2021-04-23 |
| K202750 | Knee+ | Pixee Medical | SBF | Class II | 2021-04-21 |
| K210121 | ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas | OLO | Class II | 2021-04-19 |
| K203616 | Brainsway Deep (DTMS) System | Brainsway , Ltd. | QMD | Class II | 2021-04-16 |
| K203751 | OMNIVision system | Corin USA | OLO | Class II | 2021-04-12 |
| K191479 | Velocity Alpha Highspeed Surgical Drill System | Adeor Medical AG | HBE | Class II | 2021-04-11 |
| K193630 | hekaDrill | Zethon, Ltd. | HBC | Class II | 2021-04-09 |
| K203816 | DeGen Navigated Instrumentation | Degen Medical | OLO | Class II | 2021-04-02 |
| K210251 | ClearPath Disposable Introducer | Clearmind Biomedical | GWG | Class II | 2021-04-02 |
| K210668 | TSolution One Total Knee Application | THINK Surgical, Inc. | OLO | Class II | 2021-04-01 |
| K210616 | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | GXN | Class II | 2021-03-31 |
| K203827 | REMI | Epitel, Inc. | OMC | Class II | 2021-03-29 |
| K203505 | DORO QR3 Headrest System (Aluminum) | Pro Med Instruments GmbH | HBL | Class II | 2021-03-29 |
| DEN200050 | Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc. | QCF | Class II | 2021-03-26 |
| K201426 | MyCRO Band | Otto Bock Healthcare LP | MVA | Class II | 2021-03-26 |
| K210638 | i-ED COIL System | Kaneka Medical America, LLC | HCG | Class II | 2021-03-26 |
| K202725 | ETD4000 | Therasigma, LLC | LIH | Class II | 2021-03-26 |
| K203547 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | GZB | Class II | 2021-03-25 |
| K201376 | ANAM Test System | Vista Lifesciences, Inc. | POM | Class II | 2021-03-25 |
| K200177 | Low-frequency Multi-function physiotherapy instrument | Shenzhen Kentro Medical Electronics Co., Ltd. | NUH | Class II | 2021-03-25 |
| K202186 | TrueRelief Device | Truerelief | GZJ | Class II | 2021-03-23 |
| K203205 | Navigated Spine Instruments | Stryker Spine | OLO | Class II | 2021-03-23 |
| K210555 | 7D Surgical System - Drill Guide | 7D Surgical, Inc. | OLO | Class II | 2021-03-23 |
| K210472 | SPINEART Navigation Instrument System | Spineart | OLO | Class II | 2021-03-19 |
| K203679 | Automatic Registration | Brainlab AG | OLO | Class II | 2021-03-18 |
| K200925 | Clarus Peel-Away Introducer Sheath | Clarus Medical, LLC | GWG | Class II | 2021-03-18 |
| K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Hivox Biotek, Inc. | NUH | Class II | 2021-03-10 |
| K201678 | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | GZL | Class II | 2021-03-08 |
| K202913 | NeuroCap (Model DEC22) | Memory MD, Inc. | GXY | Class II | 2021-03-05 |
| K203358 | Solitaire X Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL | Class II | 2021-03-01 |
| DEN200017 | Q-Collar | Q30 Sports Science, LLC | QNX | Class II | 2021-02-26 |
| K202956 | Erisma LP Navigated Instruments | Clariance, Sas | OLO | Class II | 2021-02-26 |
| K202184 | Practical Navigation Surgical Guidance System (PNSGS) | Practical Navigation, LLC | OLO | Class II | 2021-02-24 |
| K210202 | BioWaveGO RX | Biowave Corporation | GZJ | Class II | 2021-02-24 |
| K201906 | Trinity ELE Plus and Trinity ELE Plus Pro | Carol Cole Company Dba Nuface | NFO | Class II | 2021-02-24 |
| K201680 | NuFACE Mini Plus | Carole Cole Company | NFO | Class II | 2021-02-19 |
| K203419 | Relivion | Neurolief , Ltd. | PCC | Class II | 2021-02-16 |
| K203546 | gammaCore Sapphire | Electrocore, Inc. | PKR | Class II | 2021-02-12 |
| K202174 | Digital NeuroPort Biopotential Signal Processing System | Blackrock Microsystems | GWL | Class II | 2021-02-10 |
| K203079 | MR Conditional Sticky Pad Electrode | Rhythmlink International, LLC | GXY | Class II | 2021-02-09 |
| K203055 | Stryker PEEK Customized Cranial Implant Kit | Stryker | GWO | Class II | 2021-02-09 |
| K200276 | SPEAC System | Brain Sentinel, Inc. | POS | Class II | 2021-02-06 |
| K203573 | RESPONSE Navigation Instruments | OrthoPediatrics Corp. | OLO | Class II | 2021-02-04 |
| K192568 | Jiajian Self-Adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd. | GXY | Class II | 2021-02-03 |
| K201752 | Disposable Pre-calibrated Suction | Brainlab AG | HAW | Class II | 2021-01-29 |
6,130 clearances in the Neurology panel. Data: openFDA.