Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 43
- Latest Decision
- 2021-01-28
Clearances · page 12 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K200384 | HipXpert 3D Display and Anchoring Application | Surgical Planning Associates, Inc. | OSF | Class II | 2021-01-28 |
| K203181 | Nerivio, FGD000075-4.7 | Theranica Bioelectronics , Ltd. | QGT | Class II | 2021-01-22 |
| K202575 | ClearPoint Array System | ClearPoint Neuro, Inc. | HAW | Class II | 2021-01-22 |
| K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | NHI | Class II | 2021-01-22 |
| K201782 | NuFace Trinity Plus Device | Carol Cole Company Dba Nuface | NFO | Class II | 2021-01-22 |
| K202769 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | OLO | Class II | 2021-01-14 |
| K202694 | Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family) | Vycor Medical, Inc. | GZT | Class II | 2021-01-14 |
| K203639 | StealthStation Cranial Software v1.3.2 | Medtronic Navigation, Inc. | HAW | Class II | 2021-01-13 |
| K203561 | ChoiceSpine Navigation System | Choice Spine, LLC | OLO | Class II | 2021-01-04 |
| K201873 | Sparrow Therapy System | Spark Biomedical, Inc. | PZR | Class II | 2021-01-02 |
| K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | GWQ | Class II | 2020-12-30 |
| K203219 | Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever | Stryker Neurovascular | POL | Class II | 2020-12-29 |
| K201747 | 8-CH Electroencephalography Amplifier | Hipposcreen Neurotech Corp. | GWL | Class II | 2020-12-27 |
| K202485 | ImPACT Version 4 | Impact Applications, Inc. | POM | Class II | 2020-12-25 |
| K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System | Brainlab AG | OLO | Class II | 2020-12-23 |
| K201458 | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | GZJ | Class II | 2020-12-23 |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | AtriCure, Inc. | GXH | Class II | 2020-12-23 |
| K202159 | actiTENS | Sublimed | GZJ | Class II | 2020-12-22 |
| K202849 | Everyway Analog OTC TENS, model N103A/N302 | Everyway Medical Instruments Co.,Ltd | NUH | Class II | 2020-12-22 |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | GXI | Class II | 2020-12-22 |
| K201910 | EZTrack | Neurologic, LLC | OLX | Class II | 2020-12-22 |
| K202749 | ADAPT for Gamma3 | Stryker GmbH | OLO | Class II | 2020-12-18 |
| K203349 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | GXN | Class II | 2020-12-16 |
| K200376 | Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration | Navbit Pty, Ltd. | OLO | Class II | 2020-12-10 |
| K202334 | Neuronaute | Bioserenity Sas | GWQ | Class II | 2020-12-10 |
| K203291 | CD Horizon Spinal System Instruments | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2020-12-08 |
| K202588 | BNA Platform | Elminda, Ltd. | OLU | Class II | 2020-12-07 |
| K200719 | NuVasive Navigation.S Instruments | Nu Vasive, Incorporated | OLO | Class II | 2020-12-02 |
| K201308 | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | GWG | Class II | 2020-11-27 |
| K202470 | Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 | Everyway Medical Instruments Co.,Ltd | NUH | Class II | 2020-11-25 |
| K200402 | DR-HO'S Electro Therapy Conductive Gel | Guangzhou Xinbo Electronic Co., Ltd. | GYB | Class II | 2020-11-25 |
| K193346 | Codman Surgical Patties & Strips | Integra LifeSciences Corporation | HBA | Class II | 2020-11-20 |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL | Class II | 2020-11-20 |
| K201158 | NeuroStar Advanced Therapy | Neuronetics, Inc. | OBP | Class II | 2020-11-20 |
| K202317 | Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 | Everyway Medical Instruments Co.,Ltd | NUH | Class II | 2020-11-13 |
| K203040 | TSolution One Total Knee Application | THINK Surgical, Inc. | OLO | Class II | 2020-11-13 |
| K203082 | Insight Infrared Video Goggles | Vestibular First | GWN | Class II | 2020-11-12 |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits | Boston Scientific Neuromodulation | GZB | Class II | 2020-11-09 |
| K203110 | iFuse Implant System - iFuse Navigation | SI-BONE, Inc. | OLO | Class II | 2020-11-09 |
| K201431 | OGYILI TENS/NMES Stimulator | Gongguan Tutamen Metalwork Co., Ltd. | GZJ | Class II | 2020-11-09 |
| DEN200033 | NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable | Nightware, Inc. | QMZ | Class II | 2020-11-06 |
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) | Rebound Therapeutics | GWG | Class II | 2020-11-04 |
| K202552 | Midas Rex Attachments and Dissecting Tools | Medtronic Powered Surgical Solutions (Mpss) | OLO | Class II | 2020-11-02 |
| K202901 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | GXN | Class II | 2020-10-30 |
| K202142 | Sleepware G3 | Respironics, Inc. | OLZ | Class II | 2020-10-29 |
| K200759 | NIM Vital, Nerve Integrity Monitor | Medtronic Xomed, Inc. | GWF | Class II | 2020-10-28 |
| K202152 | NextAR TKA Platform | Medacta International S.A. | SBF | Class II | 2020-10-27 |
| K203005 | Mazor X | Mazor Robotics , Ltd. | OLO | Class II | 2020-10-27 |
| K201335 | Li-Battery powered OTC TENS/EMS Combination Stimulator | Everyway Medical Instruments Co.,Ltd | NUH | Class II | 2020-10-24 |
| K201824 | Nerivio | Theranica Bio-Electronics, Ltd. | QGT | Class II | 2020-10-23 |
| K201610 | IonicRF Generator | ABBOTT MEDICAL | GXD | Class II | 2020-10-21 |
| K200237 | Transcutaneous Electronic Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. | NUH | Class II | 2020-10-19 |
| K202609 | Instrument Clamps Electromagnetic | Stryker Corporation | PGW | Class II | 2020-10-09 |
| K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update | Brainlab AG | HAW | Class II | 2020-10-08 |
| K192077 | Tua Face Fitness / Tua Trend Face | Vupiesse S.R.L | NFO | Class II | 2020-09-30 |
| K201895 | Cefaly Dual | Cefaly Technology | PCC | Class II | 2020-09-29 |
| K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | GWQ | Class II | 2020-09-29 |
| K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) | Shenzhen Kentro Medical Electronics Co., Ltd. | NUH | Class II | 2020-09-25 |
| K193276 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | GZI | Class II | 2020-09-23 |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products, LLC | GXN | Class II | 2020-09-18 |
| K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | OLO | Class II | 2020-09-16 |
| K201631 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | JXI | Class II | 2020-09-14 |
| K200845 | Navigation Module of the Momentum System | Ulrich Medical USA | OLO | Class II | 2020-09-10 |
| K192653 | Perseus | Orthokey Italia S.R.L. | OLO | Class II | 2020-09-09 |
| K201841 | EyeBOX | Oculogica, Inc. | QEA | Class II | 2020-09-06 |
| K193655 | MSLS6QF TENS/PMS Device | Self Doctor Care, LLC | NUH | Class II | 2020-09-04 |
| K201966 | 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array | 7D Surgical, Inc. | OLO | Class II | 2020-09-03 |
| K193618 | ExactechGPS System | Blue Ortho | OLO | Class II | 2020-09-02 |
| K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | PPT | Class II | 2020-08-31 |
| K202072 | MindsEye Expandable Port | Minnetronix Neuro, Inc. | GZT | Class II | 2020-08-26 |
| K200587 | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder | Orthosensor, Inc. | ONN | Class II | 2020-08-25 |
| K200957 | Brainsway Deep TMS System | Brainsway , Ltd. | QMD | Class II | 2020-08-21 |
| K200848 | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit | Micron Medical Corporation | GZF | Class II | 2020-08-14 |
| K181645 | StimaWELL 120MTRS | Pierenkemper GmbH | GZJ | Class II | 2020-08-13 |
| K201174 | TruDi Curette | Acclarent, Inc. | PGW | Class II | 2020-08-12 |
| K200534 | VisualEyes | Interacoustics A/S | GWN | Class II | 2020-08-12 |
| K201054 | SOMNOscreen plus | Somnomedics GmbH | OLV | Class II | 2020-08-12 |
| K200838 | Tyece OTC TENS Model | Tyece Limited | NUH | Class II | 2020-08-12 |
| K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | QCI | Class II | 2020-08-09 |
| K201006 | K2M Navigation Instruments | K2m, Inc. | OLO | Class II | 2020-08-07 |
| K201251 | CarboClear Navigated Instruments | CarboFix Orthopedics , Ltd. | OLO | Class II | 2020-08-05 |
| K200791 | Navigation Enabled Intruments | Medos International SARL | OLO | Class II | 2020-07-31 |
| K200803 | BEAR and BEAR mini | Foreo, Inc. | NFO | Class II | 2020-07-31 |
| K192663 | Joimax Intracs System | Joimax GmbH | OLO | Class II | 2020-07-30 |
| K200383 | Wiggins Medical Surgical Instruments | Wiggins Medical | HAE | Class II | 2020-07-21 |
| K200387 | Ace Medical Surgical Instruments | Ace Medical | HAE | Class II | 2020-07-21 |
| K201618 | Nalu Neurostimulation SCS system | Boston Scientific Neuromodulation | GZB | Class II | 2020-07-15 |
| K193515 | Mako Total Knee Application | Mako Surgical Corp. | OLO | Class II | 2020-07-14 |
| K193559 | NextAR TKA Platform | Medacta Inernational SA | SBF | Class II | 2020-07-10 |
| K200047 | ExcelsiusGPS Cranial 1.0 Module | Globus Medical, Inc. | OLO | Class II | 2020-07-10 |
| K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch | Jkh Health Co., Ltd. | NUH | Class II | 2020-07-01 |
| K200354 | Electronic stimulator | Shenzhen Dongjilian Electronics Co., Ltd. | NUH | Class II | 2020-06-29 |
| K200888 | OMNIBotics Knee System | Corin, Ltd. | OLO | Class II | 2020-06-27 |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | Medtronic Navigation, Inc. | PGW | Class II | 2020-06-26 |
| K200095 | Streamline Navigated Instruments | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | OLO | Class II | 2020-06-26 |
| K192549 | Byteflies Kit | Byteflies NV | OMC | Class II | 2020-06-22 |
| K201327 | NavLock Trackers | Medtronic Navigation | OLO | Class II | 2020-06-18 |
| K200892 | Harvey(R) Surgical Assistant | Orthalign, Inc. | OLO | Class II | 2020-06-18 |
| K200727 | TENS and Muscle Stimulator | Shenzhen Astec Technology Co., Ltd. | NUH | Class II | 2020-06-18 |
| K192201 | Electrical Stimulator System | Gymmax Technology Shenzen Co., Ltd. | NUH | Class II | 2020-06-12 |
6,130 clearances in the Neurology panel. Data: openFDA.