Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 41
- Latest Decision
- 2023-05-09
Clearances · page 8 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K223825 | Tens & Ems Device | Shenzhen Jian Feng Electronic Technology Co., Ltd. | NUH | Class II | 2023-05-09 |
| K223428 | Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) | Shenzhen Leqing Medical Instrument Co., Ltd. | NUH | Class II | 2023-05-08 |
| K230989 | Rod Registration Frame | Nu Vasive, Incorporated | OLO | Class II | 2023-05-05 |
| K230619 | Hubly Electric Drill (H100) | Hubly, Inc. | HBE | Class II | 2023-05-04 |
| K230880 | CoreLink Navigation Instruments | Corelink, LLC | OLO | Class II | 2023-05-02 |
| K223511 | Excella Navigation Instruments | Innovasis, Inc. | OLO | Class II | 2023-05-02 |
| K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | GWQ | Class II | 2023-04-27 |
| K213078 | Myolift QT | Johari Digital Healthcare Limited | NFO | Class II | 2023-04-27 |
| K223734 | ENT EM | Brainlab AG | PGW | Class II | 2023-04-27 |
| K230829 | TENS7000 Rechargeable (Model:TENS7000 Rechargeable) | Chongqing Rob Linka Science and Technology Co., Ltd. | NUH | Class II | 2023-04-26 |
| K230202 | TMINI Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2023-04-25 |
| K230789 | Knee+ | Pixee Medical | SBF | Class II | 2023-04-21 |
| K222291 | Paradigm System | Proprio, Inc. | OLO | Class II | 2023-04-21 |
| K230783 | Anatase Spine Surgery Navigation System | Remex Medical Corp. | OLO | Class II | 2023-04-21 |
| K223238 | STARband 3D | Orthomerica Products, Inc. | MVA | Class II | 2023-04-20 |
| K223552 | Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Brainlab AG | HAW | Class II | 2023-04-19 |
| K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | GZL | Class II | 2023-04-18 |
| DEN220059 | NTX100 Tonic Motor Activation (NTX100 ToMAc) System | Noctrix Health, Inc. | QWD | Class II | 2023-04-17 |
| K223577 | Localite TMS Navigator TS | Localite GmbH | HAW | Class II | 2023-04-17 |
| K221303 | Neuspera Nuity System | Neuspera Medical, Inc. | GZF | Class II | 2023-04-11 |
| K230164 | TENS and EMS Stimulation (OTC) | Changsha Yuwen Medical Equipment Co., Ltd. | NUH | Class II | 2023-04-10 |
| K223640 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | Axogen Corporation | JXI | Class II | 2023-04-07 |
| K230064 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics , Ltd. | OLO | Class II | 2023-04-07 |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | OBP | Class II | 2023-04-04 |
| K223305 | Trevo NXT ProVue Retriever | Stryker Neurovascular | POL | Class II | 2023-03-29 |
| K230243 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | OLO | Class II | 2023-03-29 |
| K221589 | Starly pad | Shenzhen Xingyuanli Technology Co., Ltd. | GXY | Class II | 2023-03-24 |
| K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | OLO | Class II | 2023-03-23 |
| K230533 | Motive Electrode | Cymedica Orthopedics, Inc. | GXY | Class II | 2023-03-22 |
| K223086 | Ceribell Instant EEG Headcap | Ceribell, Inc. | GXY | Class II | 2023-03-22 |
| K230174 | TENS and EMS Stimulation (OTC) | Changsha Yuwen Medical Equipment Co., Ltd. | NUH | Class II | 2023-03-20 |
| K230163 | TENS and EMS Stimulation (OTC) | Changsha Yuwen Medical Equipment Co., Ltd. | NUH | Class II | 2023-03-20 |
| K222101 | Prism | Graymatters Health , Ltd. | HCC | Class II | 2023-03-17 |
| K221544 | MagVenture TMS Atlas Neuro Navigation System | Tonica Elektronik A/S | HAW | Class II | 2023-03-17 |
| K221772 | NeuroRPM | New Touch Digital, Inc. | GYD | Class II | 2023-03-17 |
| K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ | Magstim Company, Ltd. | OBP | Class II | 2023-03-16 |
| K222838 | iSyncBrain©-C | iMediSync, Inc. | OLU | Class II | 2023-03-16 |
| K220122 | APEX 6 | Rf Innovations, Inc. | GXD | Class II | 2023-03-15 |
| K223350 | Remi Robotic Navigation System | Fusion Robotics, LLC | OLO | Class II | 2023-03-13 |
| K221129 | CloudTMS for OCD | Teleemg, LLC | QCI | Class II | 2023-03-10 |
| K222355 | PathKeeper System | Pathkeeper Surgical , Ltd. | OLO | Class II | 2023-03-08 |
| K230256 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | HAE | Class II | 2023-03-03 |
| K223628 | NEBA® Compact EEG2R Mobile Headset | Neba Health, LLC | OMC | Class II | 2023-03-02 |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | HAW | Class II | 2023-02-22 |
| K230180 | Rosa Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | 2023-02-22 |
| K221469 | PATI (Protector Against Tongue Injury) | Neurovice, LLC | JXL | Class II | 2023-02-22 |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System | Stryker Corporation | HAW | Class II | 2023-02-16 |
| K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System | Stryker Leibinger GmbH & Co KG | OLO | Class II | 2023-02-13 |
| K213629 | SMILE | Nu Eyne Co., Ltd. | QGL | Class II | 2023-02-12 |
| K230073 | Okti | Compumedics Limited | GWQ | Class II | 2023-02-09 |
| K221694 | External Drainage System | Jmed(Shenzhen) Technology Limited | JXG | Class II | 2023-02-09 |
| K223169 | Nerivio | Theranica Bioelectronics , Ltd. | QGT | Class II | 2023-02-06 |
| K222680 | DeltaScan Monitor | Prolira B.V. | NCG | Class II | 2023-02-02 |
| K222671 | DeltaScan Patch | Prolira B.V. | GXY | Class II | 2023-02-02 |
| K222422 | Polaris Valve Electronic Reading Instrument | Sophysa | JXG | Class II | 2023-02-02 |
| K223330 | Certas Plus Programmable Valves | Integra Lifesciences Production Corporation | JXG | Class II | 2023-02-01 |
| K222863 | Garment Electrodes | Tone-A-Matic International, Inc. | GXY | Class II | 2023-02-01 |
| K223351 | Naviswiss Knee | Naviswiss AG | OLO | Class II | 2023-01-31 |
| K212684 | BrainView QEEG Software | Medeia, Inc. | OLU | Class II | 2023-01-28 |
| K223927 | 360CAS | Kico Knee Innovation Company Pty Limited | OLO | Class II | 2023-01-27 |
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | Spr Therapeutics, Inc. | NHI | Class II | 2023-01-25 |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | GZJ | Class II | 2023-01-24 |
| K222510 | Blueprint Mixed Reality system | Tornier S.A.S. | OLO | Class II | 2023-01-20 |
| K222848 | pRESET Thrombectomy Device | Phenox Limited | POL | Class II | 2023-01-20 |
| K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) | Medos International SARL | OLO | Class II | 2023-01-19 |
| K220448 | Disposable Non-invasive EEG Sensor | Shenzhen Med-Link Electronics Tech Co., Ltd. | GXY | Class II | 2023-01-19 |
| K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co. , Ltd. | GXY | Class II | 2023-01-19 |
| K221933 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | GXP | Class II | 2023-01-13 |
| K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ | Magstim Company, Ltd. | OBP | Class II | 2023-01-13 |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 Small | Bioserenity | GWQ | Class II | 2023-01-12 |
| K223738 | Alpha Control Liner System (ACLS) | Coapt | GXY | Class II | 2023-01-11 |
| K223200 | Curiteva Navigation System | Curiteva, Inc. | OLO | Class II | 2023-01-06 |
| K223775 | EZ-STIK Electrodes | South Dakota Partners | GXY | Class II | 2023-01-03 |
| K222002 | Persyst 15 EEG Review and Analysis Software | Persyst Development Corporation | OMB | Class II | 2022-12-30 |
| K223605 | ControlSeal Electrode (ELSB) | Coapt | GXY | Class II | 2022-12-30 |
| K223603 | Reflow System Mini and ReFlow Mini Flusher | Anuncia Medical, Inc. | JXG | Class II | 2022-12-29 |
| K223649 | VERTICALE® Navigation Instruments | Silony Medical GmbH | OLO | Class II | 2022-12-22 |
| K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) | Andon Health Co, Ltd. | NUH | Class II | 2022-12-21 |
| K220554 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | SBF | Class II | 2022-12-16 |
| K222533 | Target Tetra Detachable Coils | Stryker Neurovascular | HCG | Class II | 2022-12-14 |
| K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx | Cefaly Technology | PCC | Class II | 2022-12-13 |
| K222770 | Conductive Gel | Top-Rank Health Care Co., Ltd. | GYB | Class II | 2022-12-13 |
| K220774 | RobPath® Total Hip Application | Hangzhou Lancet Robotics Co., Ltd. | OLO | Class II | 2022-12-09 |
| K222753 | SeaSpine 7D Navigation Instruments | SeaSpine Orthopedics Corporation | OLO | Class II | 2022-12-09 |
| K222471 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA | JXG | Class II | 2022-12-08 |
| K223386 | Optima Coil System | Balt USA, LLC | HCG | Class II | 2022-12-06 |
| K222706 | iCE-SG2 Subcutaneous Electrode Kit | Ice Neurosystems, Inc. | GZL | Class II | 2022-12-06 |
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft , Ltd. | OLT | Class II | 2022-11-30 |
| K222237 | Cala kIQ | Cala Health, Inc. | QBC | Class II | 2022-11-22 |
| K221123 | WISE Cortical Strip (WCS) | Wise S.R.L. | GYC | Class II | 2022-11-22 |
| K221471 | E3 and Profile | Diagnosys, LLC | GWE | Class II | 2022-11-22 |
| K212936 | Vision Monitor- MonCvONE | Metrovision | GWE | Class II | 2022-11-21 |
| K220820 | Parky App | H2o Bilisim Yazilim | GYD | Class II | 2022-11-17 |
| K220905 | xvision Spine System | Augmedics, Ltd. | SBF | Class II | 2022-11-17 |
| K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | HBE | Class II | 2022-11-15 |
| K222488 | Everyway Analog OTC TENS | Everyway Medical Instruments Co.,Ltd | NUH | Class II | 2022-11-15 |
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | Spes Medica Srl | GYC | Class II | 2022-11-10 |
| K222453 | Self-adhesive Electrode | Guangdong Comytens Medical Technology Co., Ltd. | GXY | Class II | 2022-11-04 |
| K213697 | ORiGO System | Bien-Air Surgery SA | HBC | Class II | 2022-10-31 |
| K214109 | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | Kontour(XiAn) Medical Technology Co., Ltd. | GXN | Class II | 2022-10-28 |
6,130 clearances in the Neurology panel. Data: openFDA.