Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 43
- Latest Decision
- 2022-10-28
Clearances · page 9 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K223070 | Remi Robotic Navigation System | Fusion Robotics, LLC | OLO | Class II | 2022-10-28 |
| K222966 | Cirq Arm System (2.0);Alignment System Spine | Brainlab AG | OLO | Class II | 2022-10-27 |
| K222281 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | GXI | Class II | 2022-10-26 |
| K221563 | Neurosteer EEG Recorder | Neurosteer, Inc. | OMC | Class II | 2022-10-24 |
| K221443 | PureLift Pro Plus | Xtreem Pulse, LLC | NFO | Class II | 2022-10-21 |
| K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | GWO | Class II | 2022-10-21 |
| K221992 | Electronic Pulse Stimulator | Beijing Choice Electronic Technology Co., Ltd. | NUH | Class II | 2022-10-21 |
| K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | GZL | Class II | 2022-10-20 |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | Integra Lifesciences Production Corporation | JXG | Class II | 2022-10-14 |
| K222698 | CUVIS-spine | Curexo, Inc. | OLO | Class II | 2022-10-07 |
| K221818 | Rebellion; Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | HAE | Class II | 2022-10-07 |
| K221928 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | OLO | Class II | 2022-10-04 |
| K222383 | Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2022-09-29 |
| K213034 | SpineAR SNAP | Surgical Theater, Inc. | SBF | Class II | 2022-09-29 |
| K221918 | ReFlow System Mini | Anuncia Medical, Inc. | JXG | Class II | 2022-09-29 |
| K221724 | Conductive Gel | Tone-A-Matic International, Inc. | GYB | Class II | 2022-09-23 |
| K220681 | Talee, Talee PostOP | Invent Medical USA, LLC | MVA | Class II | 2022-09-22 |
| K221179 | SomnoMetry | Neumetry Medical, Inc. | OLZ | Class II | 2022-09-21 |
| K220553 | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering , Ltd. | GZL | Class II | 2022-09-16 |
| K222519 | ClearPoint System | ClearPoint Neuro, Inc. | HAW | Class II | 2022-09-16 |
| K220830 | TrueBalance Surgical System | These Three Medical, LLC | ONN | Class II | 2022-09-15 |
| K212618 | iRelieve Microcurrent Pain Relief System | Fast Track Technologies, Inc. | GZJ | Class II | 2022-09-14 |
| K221425 | Primary Relief | Dyansys, Inc. | NHI | Class II | 2022-09-13 |
| K221092 | Transcutaneous Electrical Nerve Stimulator Model: ST-304 | Shenzhen Future Electronic Co., Ltd. | NUH | Class II | 2022-09-13 |
| K220002 | Dexus Prosthetics System (Model: MSL1, MSR1) | Zhejiang Qiangnao Technology Co.,Ltd | GXY | Class II | 2022-09-09 |
| K213989 | Cranial EM System | Brainlab AG | HAW | Class II | 2022-09-08 |
| K220920 | Matreneu Percutaneous Balloon Compression Kit | Shenzhen Shineyard Medical Device Co. , Ltd. | HAO | Class I | 2022-09-07 |
| K220104 | Knee+ | Pixee Medical | SBF | Class II | 2022-09-01 |
| K220177 | Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K | Magnus Medical, Inc. | OBP | Class II | 2022-09-01 |
| K220997 | Wireless TENS/EMS, Bruno, Aela | Zmi Elecronics , Ltd. | NUH | Class II | 2022-09-01 |
| K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System | Brainlab AG | OLO | Class II | 2022-08-30 |
| K220819 | BrainsWay Deep TMS System | Brainsway , Ltd. | OBP | Class II | 2022-08-26 |
| K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | GZJ | Class II | 2022-08-26 |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | Medcad | GXN | Class II | 2022-08-26 |
| K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | Shenzhen Kentro Medical Electronics Co., Ltd. | NUH | Class II | 2022-08-24 |
| K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health | Neuronetics, Inc. | OBP | Class II | 2022-08-24 |
| K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | HBE | Class II | 2022-08-23 |
| K221224 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | OLO | Class II | 2022-08-19 |
| K220897 | Disposable Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | HAW | Class II | 2022-08-17 |
| K220056 | iSyncWave | iMediSync, Inc. | GWQ | Class II | 2022-08-10 |
| K220241 | POINT Kinguide Robotic-Assisted Surgical System | Point Robotics MedTech, Inc. | OLO | Class II | 2022-08-09 |
| K213876 | Spineology Navigation Instruments | Spineology, Inc. | OLO | Class II | 2022-08-05 |
| K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) | Well-Life Healthcare Limited | NUH | Class II | 2022-08-04 |
| K220139 | QScreen | Path Medical GmbH | GWJ | Class II | 2022-08-03 |
| K220733 | OptiVu ROSA MxR | Orthosoft Inc (D/B/A Zimmer Cas) | SBF | Class II | 2022-07-29 |
| K221251 | Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) | Guangzhou Huakai Electronic Technology Co., Ltd. | NUH | Class II | 2022-07-29 |
| K220958 | Real Intelligence Cori | Blue Belt Technologies, Inc. | OLO | Class II | 2022-07-27 |
| K211346 | BLUE 400 | Carl Zeiss Meditec, AG | QFX | Class II | 2022-07-22 |
| K221823 | Cionic Neural Sleeve NS-100 | Cionic | GZI | Class II | 2022-07-21 |
| K221037 | TruDi Shaver Blade | Acclarent, Inc. | PGW | Class II | 2022-07-20 |
| K210665 | Nerve Tape | Biocircuit Technologies, Incorporated | JXI | Class II | 2022-07-15 |
| K220631 | NomadAir PMU810 | Neurotronics, Inc. | GWL | Class II | 2022-07-15 |
| K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | Neuronetics, Inc. | OBP | Class II | 2022-07-15 |
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems | Medos International SARL | HCG | Class II | 2022-07-14 |
| K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | OLO | Class II | 2022-07-14 |
| K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V | Remex Medical Corporation | OLO | Class II | 2022-07-14 |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Stryker Corporation | PGW | Class II | 2022-07-12 |
| K220573 | Noodle | Pourang Bral, Dds, LLC | NUH | Class II | 2022-07-09 |
| K213873 | SkyWalker Total Knee System | Microport Navibot International, LLC | OLO | Class II | 2022-07-07 |
| K220024 | ChoiceSpine Navigation System | Choice Spine, LLC | OLO | Class II | 2022-07-06 |
| K213007 | Cerebra Sleep System | Cerebra Medical , Ltd. | OLV | Class II | 2022-07-06 |
| K221028 | SURGIVISIO Device | Ecential Robotics | OLO | Class II | 2022-07-06 |
| K203134 | Hanger Cranial Band 3D | Symbion Logistics, LLC | MVA | Class II | 2022-07-01 |
| K221524 | Sugita AVM Microclip Applier | Mizuho America, Inc. | HCI | Class II | 2022-06-24 |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson end | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | HBF | Class II | 2022-06-20 |
| K212788 | Seer Home | Seer Medical Pty, Ltd. | GWQ | Class II | 2022-06-16 |
| K212325 | EEG-acp | Somnomedics GmbH | GYB | Class II | 2022-06-15 |
| K221384 | Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 | Hivox Biotek, Inc. | NUH | Class II | 2022-06-11 |
| K221376 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | GZB | Class II | 2022-06-10 |
| K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | GYD | Class II | 2022-06-10 |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | Medtronic Navigation, Inc. | HAW | Class II | 2022-06-10 |
| K213587 | MyCRO Band | Otto Bock Healthcare LP | MVA | Class II | 2022-06-09 |
| K213882 | EarliPoint System | Earlitec Diagnostics, Inc. | QPF | Class II | 2022-06-08 |
| K221231 | Drug Relief v1 | Dyansys, Inc. | PZR | Class II | 2022-06-06 |
| K210741 | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | HAE | Class II | 2022-06-03 |
| K220652 | Knee 3 | Brainlab AG | OLO | Class II | 2022-06-03 |
| K220973 | CoreLink Navigation Instruments | Corelink, LLC | OLO | Class II | 2022-06-01 |
| K220146 | VisAR | Novarad Corporation | OLO | Class II | 2022-05-27 |
| K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | OLO | Class II | 2022-05-27 |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | GZJ | Class II | 2022-05-25 |
| K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2022-05-25 |
| K220656 | iovera System | Pacira Biosciences, Inc. | GXH | Class II | 2022-05-20 |
| K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame) | 7D Surgical | OLO | Class II | 2022-05-20 |
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | The Anspach Effort, Inc. | HBC | Class II | 2022-05-19 |
| DEN210046 | Quell-FM | Neurometrix, Inc. | QSQ | Class II | 2022-05-18 |
| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) | Thompson Surgical Instruments, Inc. | GZT | Class II | 2022-05-13 |
| K213491 | Universal Pilot Guidance Instrument System | Ctl Medical Corporation | OLO | Class II | 2022-05-12 |
| K220397 | ANSiStim-PP | Dyansys, Inc. | NHI | Class II | 2022-05-12 |
| K213299 | Wireless EEG System | Pascall Systems, Inc. | OLT | Class II | 2022-05-11 |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar | Neuronetics, Inc. | QCI | Class II | 2022-05-06 |
| K213900 | WAVi SCAN EEG System and Accessories | Wavi Co. | GWQ | Class II | 2022-05-06 |
| K213884 | Disposable EEG cable | Shenzhen Changke Connect Electronics Co., Ltd. | GXY | Class II | 2022-05-06 |
| K213788 | TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) | Dongguan Bohuikang Technology Co.,Ltd | NUH | Class II | 2022-05-06 |
| K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | OLO | Class II | 2022-05-05 |
| K214065 | ROSA ONE Brain application | Medtech S.A.S | HAW | Class II | 2022-05-04 |
| K220283 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) | Hong Qiangxing (Shenzhen) Electronics Limited | NUH | Class II | 2022-05-02 |
| K213877 | ExactechGPS® System | Blue Ortho | OLO | Class II | 2022-05-02 |
| K220038 | Camber Spine Navigation System | Camber Spine Technologies | OLO | Class II | 2022-04-29 |
| K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | Myolyn, LLC | GZI | Class II | 2022-04-25 |
| K220503 | TENS device-EmeTerm 2, Model: YF-ZTY-E2 | Wat Medical Technology, Inc. | GZJ | Class II | 2022-04-23 |
6,130 clearances in the Neurology panel. Data: openFDA.