Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 43
- Latest Decision
- 2023-11-09
Clearances · page 7 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K231920 | Longeviti ClearFit OTS Cranial Implant | Longeviti Neuro Solutions, LLC | GXN | Class II | 2023-11-09 |
| K231366 | Neuronaute Plus | Bioserenity Sas | GWQ | Class II | 2023-11-09 |
| K232152 | NerivioInfinity | Theranica Bioelectronics , Ltd. | QGT | Class II | 2023-11-08 |
| K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | HCG | Class II | 2023-11-07 |
| K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed, Inc. | NUH | Class II | 2023-11-03 |
| K232176 | STELLAR Knee | Polarisar, Inc. | SBF | Class II | 2023-11-02 |
| K232345 | ATEC Posterior Navigated Disc Prep Instruments | Alphatec Spine, Inc. | OLO | Class II | 2023-11-02 |
| K232029 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | JXI | Class II | 2023-11-02 |
| K230814 | VRNT | Cognifisense, Inc. | QRA | Class II | 2023-10-31 |
| K232280 | NextAR TSA Platform | Medacta International S.A. | SBF | Class II | 2023-10-29 |
| K230826 | Modius Sleep | Neurovalens , Ltd. | QJQ | Class II | 2023-10-27 |
| K231494 | CoreLink Robotic Navigation Instruments | Corelink, LLC | OLO | Class II | 2023-10-27 |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | GWF | Class II | 2023-10-27 |
| K232618 | Aurora Surgiscope System | Rebound Therapeutics Corporation | GWG | Class II | 2023-10-27 |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | AtriCure, Inc. | GXH | Class II | 2023-10-26 |
| K230284 | Penumbra LP Coil System | Penumbra, Inc. | HCG | Class II | 2023-10-25 |
| K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro | The Magstim Company , Ltd. | OBP | Class II | 2023-10-25 |
| K231539 | pRESET LITE Thrombectomy Device | Phenox Limited | POL | Class II | 2023-10-21 |
| K230459 | C.C. Life 21 | 21 Equipment S.R.L. | NFO | Class II | 2023-10-19 |
| K231664 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA, Inc. | JXG | Class II | 2023-10-19 |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | HAW | Class II | 2023-10-19 |
| K230125 | Neuroblade System | Clearmind Biomedical | GWG | Class II | 2023-10-13 |
| K231708 | 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 | 2023-10-12 |
| K231475 | MONTAGE-QS Settable, Resorbable Bone Putty | Orthocon, Inc. | GXP | Class II | 2023-10-12 |
| K232802 | TMINI Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2023-10-12 |
| K230148 | Vlab | Dormotech Medical, Ltd. | GWL | Class II | 2023-10-11 |
| K232044 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | OLO | Class II | 2023-10-06 |
| K232675 | Heating Tens, FT-615 | Hivox Biotek, Inc. | NUH | Class II | 2023-10-05 |
| K231527 | TriALTIS Navigation Enabled Instruments | Medos International Sàrl | OLO | Class II | 2023-09-29 |
| K230825 | Smileyscope System (Therapy Mode) | Smileyscope Holding, Inc. | QRA | Class II | 2023-09-25 |
| K232159 | QEVO System | Carl Zeiss Meditec, AG | GWG | Class II | 2023-09-21 |
| K232172 | BTL-785BNF Handpiece | BTL Industries, Inc. | NFO | Class II | 2023-09-18 |
| K231688 | ImPACT Version 4 | Impact Applications, Inc. | POM | Class II | 2023-09-16 |
| K232102 | ClearPoint Array System (Version 1.2) | ClearPoint Neuro, Inc. | HAW | Class II | 2023-09-15 |
| K220735 | Avologi Gel Primer (Model: Av25) | Premier North America, Inc. | GYB | Class II | 2023-09-15 |
| K230735 | Ultimate rTMS; Yingchi rTMS | Brain Ultimate, Inc. | OBP | Class II | 2023-09-13 |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Brainlab AG | HAW | Class II | 2023-09-09 |
| K231284 | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | SBF | Class II | 2023-09-08 |
| K231141 | STarFix Designer Software C0265 | FHC, Inc. | QRI | Class II | 2023-09-08 |
| K232413 | Fusion Robotic Navigation System | Alphatec Spine, Inc. | OLO | Class II | 2023-09-08 |
| K230661 | Zeta Cranial Navigation System | Zeta Surgical | HAW | Class II | 2023-09-08 |
| K213273 | Brain Anesthesia Response Monitor (Bar Monitor) | Cortical Dynamics , Ltd. | OLW | Class II | 2023-09-01 |
| K221959 | Q21 | Neurofield, Inc. | GWQ | Class II | 2023-08-31 |
| K231611 | HOLO Portal Surgical Guidance System | Surgalign Spine Technologies | SBF | Class II | 2023-08-31 |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | Tonica Elektronik A/S | QPL | Class II | 2023-08-25 |
| K231457 | SPARK Scan | Spark Neuro, Inc. | GWQ | Class II | 2023-08-18 |
| K231053 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | NUH | Class II | 2023-08-18 |
| K223539 | Dreem 3S | Beacon Biosignals, Inc. | OLZ | Class II | 2023-08-18 |
| K230415 | Cadwell Guardian | Cadwell Industries, Inc. | GWF | Class II | 2023-08-17 |
| K232116 | CoreLink Navigation Instruments | Corelink, LLC | OLO | Class II | 2023-08-16 |
| K223922 | SOMNUM (V.1.1.2.) | Honeynaps Co., Ltd. | OLZ | Class II | 2023-08-16 |
| K231208 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | HBW | Class II | 2023-08-14 |
| K223445 | ArtiFascia | Nurami Medical , Ltd. | GXQ | Class II | 2023-08-10 |
| K231164 | Conductive carbon film electrode | Guangzhou Xinbo Electronic Co., Ltd. | GXY | Class II | 2023-08-09 |
| K231167 | Conductive Silicone Rubber Electrode | Guangzhou Xinbo Electronic Co., Ltd. | GXY | Class II | 2023-08-09 |
| K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | GXY | Class II | 2023-08-08 |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab AG | OLO | Class II | 2023-08-02 |
| K231963 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | OLO | Class II | 2023-08-01 |
| K222735 | HJY VisualNext Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | GWG | Class II | 2023-07-28 |
| K231886 | SURGIVISIO Device | Ecential Robotics | OLO | Class II | 2023-07-27 |
| K231172 | ApolloKnee | Corin U.S.A. Limited | OLO | Class II | 2023-07-26 |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Acclarent, Inc. | PGW | Class II | 2023-07-21 |
| K223769 | NextAR Spine Platform | Medacta International S.A. | SBF | Class II | 2023-07-21 |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab AG | HAW | Class II | 2023-07-21 |
| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System | Spinecraft, LLC | OLO | Class II | 2023-07-20 |
| K231103 | ROSA ONE Brain Application | Medtech S.A.S | HAW | Class II | 2023-07-20 |
| K223151 | Nu-beca Transcutaneous Electrical Nerve Stimulation | Nu-Beca & Maxcellent Co. | NUH | Class II | 2023-07-19 |
| K230716 | Robotic Graft Delivery Instruments | Medtronic Sofamor Danek, Inc. | OLO | Class II | 2023-07-18 |
| K230087 | POINT Kinguide Agile Hybrid Navigation System | Point Robotics MedTech, Inc. | OLO | Class II | 2023-07-17 |
| K231392 | NaviNetics Reusable Stereotactic System (NN1000) | Navinetics, Inc. | HAW | Class II | 2023-07-14 |
| K223808 | Zavation Navigation Instrument System | Zavation Medical Products, LLC | OLO | Class II | 2023-07-12 |
| K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | OMC | Class II | 2023-06-30 |
| K223047 | NeuroSwift Pro | Neurobit Technologies Co., Ltd. | GWN | Class II | 2023-06-29 |
| K223596 | SQ.line KERRISON | Aesculap, Inc. | HAE | Class II | 2023-06-29 |
| K230337 | EarliPoint | Earlitec Diagnostics, Inc. | QPF | Class II | 2023-06-29 |
| K231691 | Phantom XL Insulated Dilators | TeDan Surgical Innovations, Inc. | GXZ | Class II | 2023-06-29 |
| K220198 | Medi Lift PLUS | Ya-Man, Ltd. | NFO | Class II | 2023-06-28 |
| K230876 | RI.KNEE Adjustable Tibia Cut Guide | Enztec Limited | OLO | Class II | 2023-06-27 |
| K230861 | VADER® Pedicle System Navigated Instruments | Icotec AG | OLO | Class II | 2023-06-27 |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC | LEL | Class II | 2023-06-23 |
| K230369 | EUROPA Navigated Instruments | MiRus, LLC | OLO | Class II | 2023-06-23 |
| K230444 | Talee, Talee PostOp | Invent Medical USA, LLC | MVA | Class II | 2023-06-22 |
| K223558 | CUVIS-spine | Curexo, Inc. | OLO | Class II | 2023-06-22 |
| K230506 | PureLift Pro Edition | Xtreem Pulse | NFO | Class II | 2023-06-21 |
| K230796 | Sparrow Ascent | Spark Biomedical, Inc. | PZR | Class II | 2023-06-20 |
| K220072 | Sinobot X1 | Sinovation (Beijing) Medical Technology Co., Ltd. | HAW | Class II | 2023-06-18 |
| K230567 | OptiVu ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) | SBF | Class II | 2023-06-13 |
| K222450 | LVIS NeuroMatch | LVIS Corporation | OMB | Class II | 2023-06-09 |
| K231350 | OCD MT Cap (85-00397-000) | Neuronetics | QCI | Class II | 2023-06-08 |
| K223676 | SomniCheck | Brainmatterz, LLC | GWL | Class II | 2023-06-01 |
| K231184 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2023-05-26 |
| K231229 | S-COMP Reform® POCT Navigation Instruments | Precision Spine, Inc. | OLO | Class II | 2023-05-25 |
| K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | OMB | Class II | 2023-05-23 |
| K230443 | TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) | Jiangxi Royall Smart Technology Co., Ltd. | NUH | Class II | 2023-05-22 |
| K223276 | Anchor Bolts as Accessories to Depth Electrodes | Ad-Tech Medical Instrument Corporation | GZL | Class II | 2023-05-18 |
| K223269 | Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | GZL | Class II | 2023-05-18 |
| K230358 | SAVI Dual (TM) Migraine Therapy | Eneura, Inc. | OKP | Class II | 2023-05-16 |
| K223308 | HEATING TENS/EMS, FT-810R | Hivox Biotek, Inc. | NUH | Class II | 2023-05-13 |
| K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 | Shenzhen Kentro Medical Electronics Co., Ltd. | NUH | Class II | 2023-05-10 |
| DEN220083 | Stanza | Swing Therapeutics, Inc. | QWI | Class II | 2023-05-09 |
6,130 clearances in the Neurology panel. Data: openFDA.