Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 45
- Latest Decision
- 2024-05-23
Clearances · page 6 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | Brainlab AG | OLO | Class II | 2024-05-23 |
| K233985 | TRIUX neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | OLX | Class II | 2024-05-15 |
| K232242 | BEAR 2 Body | Foreo, Inc. | NFO | Class II | 2024-05-13 |
| K240625 | CORUS Navigation Access System | Providence Medical Technology, Inc. | OLO | Class II | 2024-05-03 |
| K233513 | Remex Spine Surgery Navigation System II | Remex Medical Corp. | OLO | Class II | 2024-05-01 |
| K233403 | Flexset System | Zeto, Inc. | GWQ | Class II | 2024-04-30 |
| K240062 | ARVIS® Shoulder | Insight Medical Systems, Inc. | OLO | Class II | 2024-04-29 |
| K240568 | DuraPro Oscillating System | Globus Medical, Inc. | OLO | Class II | 2024-04-29 |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | HAW | Class II | 2024-04-26 |
| K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) | Pro Med Instruments GmbH | HBL | Class II | 2024-04-24 |
| K233172 | NextAR Spine Platform | Medacta International S.A. | SBF | Class II | 2024-04-24 |
| K223515 | MamaLift Plus | Curio Digital Therapeutics, Inc. | SAP | Class II | 2024-04-22 |
| K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | GWF | Class II | 2024-04-19 |
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited | GZJ | Class II | 2024-04-19 |
| K240884 | Glide (91000-GL-X) | Infinite Biomedical Technologies, LLC | GXY | Class II | 2024-04-15 |
| K240647 | Virage® Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | OLO | Class II | 2024-04-05 |
| K231834 | VSP PEEK Cranial Implant | 3D Systems, Inc. | GWO | Class II | 2024-04-04 |
| K233618 | Oxevision Sleep Device | Oxehealth Limited | LEL | Class II | 2024-04-03 |
| K231209 | Rejoyn | Otsuka America Pharmaceutical, Inc. | SAP | Class II | 2024-03-30 |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation | Genesys Spine | OLO | Class II | 2024-03-29 |
| K240567 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | GXN | Class II | 2024-03-28 |
| K232253 | Modius Stress | Neurovalens Limited | QJQ | Class II | 2024-03-27 |
| K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | NUH | Class II | 2024-03-27 |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | Soterix Medical, Inc. | GWF | Class II | 2024-03-25 |
| K240292 | Transcutaneous Electrical Nerve Stimulator (9029SCM) | Hong Kong Etech Groups Limited | NUH | Class II | 2024-03-25 |
| K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | OBP | Class II | 2024-03-22 |
| K232439 | Electrical Stimulator System | Gymmax Technology Shenzen Co., Ltd. | NUH | Class II | 2024-03-21 |
| K234047 | Automatic Registration | Brainlab AG | OLO | Class II | 2024-03-20 |
| K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | GXY | Class II | 2024-03-19 |
| K240139 | Real Intelligence CORI | Blue Belt Technologies, Inc. | OLO | Class II | 2024-03-18 |
| K240466 | STARband 3D | Orthomerica Products, Inc. | OAN | Class II | 2024-03-15 |
| K232567 | Myriad SPECTRA Light Source | Nico Corporation | QFX | Class II | 2024-03-14 |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System | Stryker Leibinger GmbH & Co KG | OLO | Class II | 2024-03-14 |
| K232140 | OTS Hip | Ortoma AB | OLO | Class II | 2024-03-11 |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | GWJ | Class II | 2024-03-08 |
| K233438 | SleepStageML | Beacon Biosignals, Inc. | OLZ | Class II | 2024-03-08 |
| K233899 | Knee+ | Pixee Medical | SBF | Class II | 2024-03-08 |
| K230195 | Neo ADVISE software | Comerge AG | OLO | Class II | 2024-03-08 |
| K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | HBF | Class II | 2024-03-06 |
| K233095 | S21 OTC Transcutaneous Electrical Nerve Stimulator | Micro Current Technology, Inc. | NUH | Class II | 2024-03-01 |
| K231648 | Muscle Stimulator | Shenzhen Yiran Intelligent Co., Ltd. | NUH | Class II | 2024-03-01 |
| K230693 | BIS Advance Monitoring System | Covidien, LLC | OLW | Class II | 2024-02-26 |
| K230782 | TENS device-HeadaTerm 2 (Model: YF-HT2) | Wat Medical Technology, Inc. | PCC | Class II | 2024-02-26 |
| K232800 | Navigation Tracking Instruments | SI-BONE, Inc. | OLO | Class II | 2024-02-23 |
| K233784 | ENSO (Model 2) | Hinge Health, Inc. | NUH | Class II | 2024-02-23 |
| K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | 2024-02-21 |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Neos Surgery S.L | GXR | Class II | 2024-02-16 |
| K232771 | Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. | GXP | Class II | 2024-02-16 |
| K232915 | EpiMonitor | Empatica S.r.l. | POS | Class II | 2024-02-15 |
| K233533 | NerveTape | Biocircuit Technologies, Inc. | JXI | Class II | 2024-02-12 |
| K233092 | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | Chongqing Rob Linka Science and Technology Co., Ltd. | NUH | Class II | 2024-02-12 |
| K233667 | Facial Toning device (UIC-189); Facial Toning device (UIC-589) | Body Trim Industrial Co., Ltd. | NFO | Class II | 2024-02-12 |
| K233040 | EMS/TENS Massager Device | Shenzhen Imdk Medical Technology Co., Ltd. | NUH | Class II | 2024-02-12 |
| K233631 | ZapStim Controller Application (Z1023) | Revital Lab, Inc. | OBP | Class II | 2024-02-09 |
| K233638 | VERZA High Speed Drills | Globus Medical, Inc. | OLO | Class II | 2024-02-09 |
| K231575 | Vecttor VT-300 | Artaflex, Inc. | LIH | Class II | 2024-02-08 |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | Integra Lifesciences Production Corporation | GWM | Class II | 2024-02-04 |
| K232210 | X-trodes System M | X-Trodes | GWL | Class II | 2024-02-04 |
| K230657 | BTL-99-OC | BTL Industries, Inc. | QCI | Class II | 2024-02-01 |
| K230794 | Rebuilder Nerve Guidance Conduit | Celestray Biotech Company, LLC., | JXI | Class II | 2024-01-29 |
| K233299 | ExactechGPS® System | Blue Ortho | OLO | Class II | 2024-01-26 |
| K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) | Shenzhen Roundwhale Technology Co. , Ltd. | NUH | Class II | 2024-01-22 |
| K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | Hi-Dow International, Inc. | NUH | Class II | 2024-01-19 |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | Integra Lifesciences Production Corporation | JXG | Class II | 2024-01-17 |
| K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Neurosigma, Inc. | QGL | Class II | 2024-01-16 |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | HAW | Class II | 2024-01-12 |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | HAW | Class II | 2024-01-12 |
| K233141 | SmartFrame OR | ClearPoint Neuro, Inc. | HAW | Class II | 2024-01-12 |
| K232995 | Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe | Shenzhen Roundwhale Technology Co. , Ltd. | GXY | Class II | 2024-01-11 |
| DEN220066 | BrainSee | Darmiyan, Inc. | QWT | Class II | 2024-01-11 |
| K233364 | Axon Therapy | Neuralace Medical, Inc. | QPL | Class II | 2024-01-10 |
| K233903 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | HAW | Class II | 2024-01-10 |
| K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | HCG | Class II | 2024-01-10 |
| K231068 | autoSCORE | Holberg Eeg AS | OMB | Class II | 2024-01-07 |
| K231779 | REMI AI Discrete Detection Module | Epitel, Inc. | OMB | Class II | 2024-01-03 |
| K232688 | NQ TMS for MDD (NQv1-MU-01) | Neuroqore, Inc. | OBP | Class II | 2023-12-29 |
| K230997 | EvoWalk 1.0 System | Evolution Devices, Inc. | GZI | Class II | 2023-12-28 |
| K231914 | Nurochek-II System | Headsafe Mfg Pty, Ltd. | PIW | Class II | 2023-12-27 |
| K233742 | CloudTMS Edge for OCD | Teleemg, LLC | QCI | Class II | 2023-12-22 |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | Integra Lifesciences Production Corporation | JXG | Class II | 2023-12-19 |
| K221199 | Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) | Green Island International Tcm Group Limited | GXY | Class II | 2023-12-19 |
| K230926 | Ova+ (K-OVAP-USA) | Tenscare, Ltd. | NUH | Class II | 2023-12-15 |
| K233227 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | OLO | Class II | 2023-12-14 |
| K232572 | Kalitec Navigated Instrument System | Kalitec Direct, LLC Doing Business AS Kalitec Medical | OLO | Class II | 2023-12-13 |
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | Neuronetics | OBP | Class II | 2023-12-13 |
| K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) | Shenzhen Kentro Medical Electronics Co., Ltd. | NUH | Class II | 2023-12-08 |
| K231675 | OneRF Ablation System | Neuroone Medical Technologies Corp. | GXD | Class II | 2023-12-06 |
| K232581 | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | GXZ | Class II | 2023-12-04 |
| K232684 | Surgify Halo | Surgify Medical OY | HBE | Class II | 2023-11-29 |
| K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | HAW | Class II | 2023-11-27 |
| K233525 | MF SC Facial Toning System | Micro Current Technology, Inc. | NFO | Class II | 2023-11-24 |
| K221606 | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | GXR | Class II | 2023-11-21 |
| K223615 | Digital ClarusScope System, Digital NeuroPEN System | Clarus Medical, LLC | GWG | Class II | 2023-11-21 |
| K230211 | CranioXpand | KLS-Martin L.P. | PBJ | Class II | 2023-11-21 |
| K233010 | Beagank 4T Plus | Belega, Inc. | NFO | Class II | 2023-11-21 |
| K232001 | Nu Skin RenuSpa iO | Nse Products, Inc. | NFO | Class II | 2023-11-21 |
| K230700 | RIWOtrack Navigation System | Fiagon GmbH | OLO | Class II | 2023-11-20 |
| K232521 | ExactechGPS® Total Ankle Application | Blue Ortho | OLO | Class II | 2023-11-16 |
| K233443 | Vital Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | OLO | Class II | 2023-11-16 |
| K232533 | ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas | OLO | Class II | 2023-11-16 |
6,130 clearances in the Neurology panel. Data: openFDA.