Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 46
- Latest Decision
- 2024-12-04
Clearances · page 5 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K243417 | RelieVRx | Appliedvr | QRA | Class II | 2024-12-04 |
| K241390 | NeuroMatch | LVIS Corporation | OMB | Class II | 2024-11-26 |
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | Eemagine Medical Imaging Solutions GmbH | GXY | Class II | 2024-11-25 |
| K243334 | Nooro Body & Foot Stimulator (SM9141, SM9142) | Xf Agencija Limited | NUH | Class II | 2024-11-22 |
| K240632 | Neuvotion NeuStim NN-01 | Neuvotion, Inc. | GZI | Class II | 2024-11-22 |
| K242094 | Dreem 3S | Beacon Biosignals, Inc. | OLZ | Class II | 2024-11-22 |
| K242259 | Cala kIQ | Cala Health, Inc. | QBC | Class II | 2024-11-22 |
| K242930 | Natus BrainWatch System | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | OMC | Class II | 2024-11-19 |
| K243285 | TMINI Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2024-11-15 |
| DEN240023 | SmartFlow Neuro Cannula | ClearPoint Neuro, Inc. | SDG | Class II | 2024-11-13 |
| K242373 | Mako Shoulder Application (1.0) | Mako Surgical Corp. | OLO | Class II | 2024-11-07 |
| K242719 | ELEXIR 2.0 (ALLIVE3) | Nu Eyne Co., Ltd. | PCC | Class II | 2024-11-06 |
| K242345 | Delphi Stimulator | Quantalx Neuroscience | GWF | Class II | 2024-11-05 |
| K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) | Shenzhen Kentro Medical Electronics Co., Ltd. | NUH | Class II | 2024-11-05 |
| K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) | Changsha Anxiang Medical Technology Co., Ltd. | NUH | Class II | 2024-11-04 |
| K242271 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | SBF | Class II | 2024-10-30 |
| K243157 | AtriCure cryoICE BOX (ACM) | AtriCure, Inc. | GXH | Class II | 2024-10-29 |
| K242034 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | PCB | Class II | 2024-10-24 |
| K242864 | ROSA® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | OLO | Class II | 2024-10-18 |
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator | Well-Life Healthcare Limited | NUH | Class II | 2024-10-18 |
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. | OMB | Class II | 2024-10-17 |
| K240160 | EGPS Navigated Instruments | Astura Medical | OLO | Class II | 2024-10-17 |
| K241481 | xvision Spine System | Augmedics, Ltd. | SBF | Class II | 2024-10-16 |
| K232779 | QUEX ED; QUEX S | Qx World, Ltd. | OMC | Class II | 2024-10-11 |
| K241756 | Nerivio; NerivioInfinity | Theranica Bio-Electronics, Ltd. | QGT | Class II | 2024-10-08 |
| K241298 | QUADSENSE | Eventum Orthopaedics, Ltd. | ONN | Class II | 2024-10-04 |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | HAW | Class II | 2024-10-04 |
| K242616 | Lantern® Hip | Orthalign, Inc. | ONN | Class II | 2024-10-03 |
| K242154 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | HCG | Class II | 2024-09-30 |
| K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | OMB | Class II | 2024-09-27 |
| K241513 | Sourcerer | Brain Electrophysiology Laboratory Company, LLC | OLX | Class II | 2024-09-27 |
| K242582 | Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC | HCG | Class II | 2024-09-27 |
| K241027 | Permatage Settable Bone Putty | Orthocon, Inc. | GXP | Class II | 2024-09-26 |
| K233153 | Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. | HBC | Class II | 2024-09-20 |
| K240420 | NeuroField Analysis Suite | Neurofield, Inc. | OLU | Class II | 2024-09-20 |
| K232938 | Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. | HBC | Class II | 2024-09-16 |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | OLO | Class II | 2024-09-16 |
| K241678 | TENS & EMS Stimulator (MHD-1083) | Shenzhen Minghuangda Electronics Co., Ltd. | NUH | Class II | 2024-09-09 |
| K240646 | DreamClear | Somnomed Technologies Inc., Doing Business AS Remware | GWL | Class II | 2024-09-04 |
| K242305 | BE Plus PRO, Neurotravel LIGHT | Eb Neuro S.P.A. | GWL | Class II | 2024-09-04 |
| K242306 | SignalNED System (Model RE) | Forest Devices, Inc. | OMC | Class II | 2024-09-04 |
| K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | GZJ | Class II | 2024-08-30 |
| K241957 | Talee, Talee PostOp | Invent Medical USA, LLC | MVA | Class II | 2024-08-30 |
| K233872 | Daylight | Big Health, Inc. | SCP | Class II | 2024-08-30 |
| K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | The Magstim Company Limited | OBP | Class II | 2024-08-30 |
| K242346 | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | GXY | Class II | 2024-08-29 |
| K242243 | Target Detachable Coils | Stryker Neurovscular | HCG | Class II | 2024-08-29 |
| K232991 | BT-1000 | Bistos Co., Ltd. | QGL | Class II | 2024-08-28 |
| K241228 | TENSWave | Zynex Medical Officer | GZJ | Class II | 2024-08-27 |
| K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | OLO | Class II | 2024-08-27 |
| K242264 | TMINI Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2024-08-23 |
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | GZB | Class II | 2024-08-23 |
| K240593 | VEEGix EEG System | NeuroServo, Inc. | OLT | Class II | 2024-08-23 |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | GZF | Class II | 2024-08-21 |
| K233391 | cCeLL - In vivo | VPIX Medical, Inc. | GWG | Class II | 2024-08-21 |
| K241458 | Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | Borvo Medical, Inc. | JXG | Class II | 2024-08-20 |
| K241870 | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | SBF | Class II | 2024-08-19 |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | Avanos Medical, Inc. | GXD | Class II | 2024-08-14 |
| K241365 | Pixie Pulse (SM9068) | Pixie Cup, LLC | NUH | Class II | 2024-08-12 |
| K233315 | HipXpert and HipInsight System | Surgical Planning Associates, Inc. | OSF | Class II | 2024-08-08 |
| K242009 | 360CAS Knee | Kico Knee Innovation Company Pty, Ltd. | OLO | Class II | 2024-08-08 |
| K241644 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | 2024-08-07 |
| K233577 | Sleepio® | Big Health, Inc. | QVO | Class II | 2024-08-05 |
| K233706 | Bendini Cloud Application | Nuvasive | OLO | Class II | 2024-08-02 |
| K233580 | A Breathing System (ABS) | Deepwell Dtx, Inc. | HCC | Class II | 2024-08-01 |
| K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) | Pro Med Instruments GmbH | HBL | Class II | 2024-07-26 |
| K233725 | Spine Navigation System | Medivis, Inc. | OLO | Class II | 2024-07-26 |
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories | Stryker Leibinger GmbH & Co KG | OLO | Class II | 2024-07-25 |
| K241130 | POINT Kinguide Agile Hybrid Navigation System (PSHF01-000) | Point Robotics MedTech, Inc. | OLO | Class II | 2024-07-24 |
| K241119 | Transcutaneous Electrical Nerve Stimulator (K6106) | Shenzhen Yicai Health Technology Co., Ltd. | NUH | Class II | 2024-07-22 |
| K233067 | Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | Chongqing Rob Linka Science and Technology Co., Ltd. | NUH | Class II | 2024-07-19 |
| K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | Braincare Desenvolvimento E Inovação Tecnológica S.A. | GWM | Class II | 2024-07-18 |
| K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology | PCC | Class II | 2024-07-18 |
| DEN230061 | allay Nerve Cap | Tulavi Therapeutics | SBG | Class II | 2024-07-16 |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1) | THINK Surgical, Inc. | OLO | Class II | 2024-07-12 |
| K241625 | Anatase Navi Disposable Instrument | Remex Medical Corp. | OLO | Class II | 2024-07-05 |
| K240215 | BLUE 400; BLUE 400 S | Carl Zeiss Meditec, AG | QFX | Class II | 2024-06-28 |
| K241509 | TENS&EMS units (SM9109A, SM9109B) | Plexus Yoga, LLC Dba Chirp | NUH | Class II | 2024-06-27 |
| K240564 | NuFACE® FIX+ | Carol Cole Company Dba Nuface® | NFO | Class II | 2024-06-27 |
| K233006 | MyndMove, MyndMove 2.0 | Myndtec, Inc. | GZI | Class II | 2024-06-25 |
| K233322 | Mochida Nerve Cuff | Mochida Pharmaceutical Co., Ltd. | JXI | Class II | 2024-06-21 |
| K233162 | Freedom Peripheral Nerve Stimulator (PNS) System | Curonix | GZF | Class II | 2024-06-20 |
| K233255 | CROSSNAV Navigation Enabled Instruments | DePuy Synthes | OLO | Class II | 2024-06-17 |
| K233987 | VERABAND | Arbor Medical Innovations, LLC | LEL | Class II | 2024-06-17 |
| K233256 | Robotic Integration Instruments | DePuy Synthes | OLO | Class II | 2024-06-17 |
| K240721 | ExcelsiusFlex | Globus Medical, Inc. | OLO | Class II | 2024-06-14 |
| K233228 | Spine Navigation and Robotic-Assistance Device | Ecential Robotics | OLO | Class II | 2024-06-14 |
| K241082 | INNOVERSE Navigation Instruments | Innosys Co., Ltd. | OLO | Class II | 2024-06-14 |
| K233254 | TELIGEN System Navigation Ready Instruments | DePuy Synthes | OLO | Class II | 2024-06-14 |
| K241011 | Mako Total Knee Application | Mako Surgical Corp. | OLO | Class II | 2024-06-11 |
| K232749 | DOOPANG | Ybrain, Inc. | PCC | Class II | 2024-06-11 |
| K240108 | Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01) | Gymmax Technology Shenzhen Co., Ltd. | GXY | Class II | 2024-06-10 |
| K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece | Stryker Leibinger GmbH & Co KG | OLO | Class II | 2024-06-06 |
| K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | OLO | Class II | 2024-06-06 |
| K240211 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | OLO | Class II | 2024-06-05 |
| K233751 | Milieve (YPS-301BD) | Soterix Medical, Inc. | PCC | Class II | 2024-06-03 |
| K222196 | Deep TMS System | Brainsway , Ltd. | OBP | Class II | 2024-05-31 |
| K233166 | NET Recovery Corp/NET Device | Net Recovery | PZR | Class II | 2024-05-29 |
| K232632 | Racz Neurostat RF Generator | Epimed International | GXD | Class II | 2024-05-24 |
| K232639 | Apollo TMS Therapy System | Mag & More GmbH | OBP | Class II | 2024-05-24 |
6,130 clearances in the Neurology panel. Data: openFDA.