Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 40
- Latest Decision
- 2018-07-13
Clearances · page 16 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K171880 | IRRAflow CNS System | Irras, Inc. | JXG | Class II | 2018-07-13 |
| K180816 | Ziehm RFD 3D Tracker | Medtronic Navigation | OLO | Class II | 2018-07-11 |
| K172971 | BMLS16-1 | Biomedical Life Systems, Inc. | NUH | Class II | 2018-07-08 |
| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | OLV | Class II | 2018-07-02 |
| K171414 | qEEG-Pro | Brainmaster Technologies, Inc. | OLU | Class II | 2018-07-01 |
| K180038 | NuVasive Pulse System | Nu Vasive, Incorporated | OLO | Class II | 2018-06-29 |
| K180865 | ZMI Self-Adhesive Electrodes | Zmi Electronics , Ltd. | GXY | Class II | 2018-06-28 |
| K180690 | Navigation Instruments | Globus Medical, Inc. | OLO | Class II | 2018-06-25 |
| K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | HBC | Class II | 2018-06-22 |
| K180331 | Wireless Pain Relieve Device | Shenzhen Dongdixin Technology Co., Ltd. | NUH | Class II | 2018-06-22 |
| K180761 | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | GYC | Class II | 2018-06-18 |
| K173936 | Natus Photic Stimulator | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | GWE | Class II | 2018-06-15 |
| K181301 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | JXG | Class II | 2018-06-14 |
| K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | GWQ | Class II | 2018-06-14 |
| K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co. , Ltd. | NUH | Class II | 2018-06-07 |
| K180459 | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | ONN | Class II | 2018-06-07 |
| K181207 | Balego TENS Digital Edition with Accessories for Pain Relief (OTC) | Everyway Medical Instruments Co., Ldt. | NUH | Class II | 2018-06-06 |
| K173093 | TAMA BEMS device | Tama Research Corporation | NFO | Class II | 2018-06-05 |
| K171798 | Silverwear Silver Pro Garment Device | Media Plus, LLC | GXY | Class II | 2018-06-01 |
| K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | LEL | Class II | 2018-05-24 |
| K180773 | Reusable and Self-Adhesive Electrodes | Shaoxing Dongzhi Electrical Technology Co., Ltd. | GXY | Class II | 2018-05-22 |
| K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | GWG | Class II | 2018-05-22 |
| K180524 | EEG-Now | Encephalodynamics, Inc. | GXY | Class II | 2018-05-18 |
| K172209 | AURA ICP MONITORING SYSTEM | Branchpoint Technologies, Inc. | GWM | Class II | 2018-05-18 |
| K181179 | BrainScope One | Brainscope Company, Inc. | PIW | Class II | 2018-05-18 |
| K181111 | Navigated INFINITY Instruments | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2018-05-17 |
| K180513 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | GXN | Class II | 2018-05-15 |
| K172517 | SeaSpine Navigation System | SeaSpine Orthopedics Corporation | OLO | Class II | 2018-05-11 |
| K172271 | Trackit T4 EEG Amplifier | Lifelines , Ltd. | GWQ | Class II | 2018-05-04 |
| K173684 | g.Estim PRO | G.Tec Medical Engineering GmbH | GYC | Class II | 2018-05-04 |
| K180313 | Apollo TMS Therapy System | Mag & More GmbH | OBP | Class II | 2018-05-04 |
| K173711 | Wallaby Avenir Coil System | Wallaby Medical, Inc. | HCG | Class II | 2018-05-04 |
| K173540 | Brainsway Deep (DTMS) System | Brainsway , Ltd. | OBP | Class II | 2018-05-03 |
| K180352 | 7D Surgical System | 7D Surgical, Inc. | OLO | Class II | 2018-05-02 |
| K173946 | ADAPT for Gamma3 | Stryker GmbH | OLO | Class II | 2018-05-02 |
| K173861 | Drug Relief | Dyansys, Inc. | PZR | Class II | 2018-05-02 |
| K180796 | Spineology Navigation Instruments | Spineology, Inc. | OLO | Class II | 2018-05-02 |
| K180307 | Mazor X | Mazor Robotics , Ltd. | OLO | Class II | 2018-04-30 |
| K172166 | OLYMPIC Navigated Instruments | Astura Medical | OLO | Class II | 2018-04-27 |
| K172866 | NeuroCap | Memory MD, Inc. | GXY | Class II | 2018-04-27 |
| K171821 | 2 Face / Face Evolution | Heat IN A Click | NFO | Class II | 2018-04-26 |
| DEN170028 | Cala ONE | Cala Health, Inc. | QBC | Class II | 2018-04-26 |
| K180206 | neuromate Gen III | Renishaw Mayfield Sarl | HAW | Class II | 2018-04-24 |
| K180222 | Reaxon Plus | Medovent GmbH | JXI | Class II | 2018-04-24 |
| K180277 | Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter | Smith & Nephew, Inc. | OLO | Class II | 2018-04-24 |
| K172478 | TENS device-EmeTerm, CinvStop | Wat Medical Technology (Ningbo) Co., Ltd. | GZJ | Class II | 2018-04-19 |
| K171720 | encevis | Ait Austrian Institute of Technology GmbH | OMB | Class II | 2018-04-19 |
| K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) | Guangzhou Xinbo Electronic Co., Ltd. | GXY | Class II | 2018-04-19 |
| K172919 | EV-804 OTC Pain Relief TENS | Everyway Medical Instruments Co.,Ltd | NUH | Class II | 2018-04-19 |
| K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | GWG | Class II | 2018-04-17 |
| K180914 | Aesculap Slim Clip Applier | Aesculap, Inc. | HCI | Class II | 2018-04-17 |
| K172735 | WR19 System | Zeto, Inc. | GWQ | Class II | 2018-04-17 |
| K173614 | Penumbra Coil 400, Ruby Coil System, POD System | Penumbra, Inc. | HCG | Class II | 2018-04-17 |
| K180271 | NAVIO Surgical System (NAVIO system) | Blue Belt Technologies, Inc. | OLO | Class II | 2018-04-06 |
| K172312 | eego amplifiers | Eemagine Medical Imaging Solutions GmbH | GWL | Class II | 2018-03-30 |
| K180538 | gammaCore Sapphire | Electrocore, LLC | PKR | Class II | 2018-03-30 |
| K172444 | ROSA BRAIN (v3.0.0.5) | Medtech S.A | HAW | Class II | 2018-03-28 |
| DEN170023 | ThermoNeuroModulation Device, TNM Device | Scion Neurostim, LLC | QAR | Class II | 2018-03-26 |
| K172035 | EKOS ultrasound EVD Device, EVD Control Unit | Btg International, Inc. | JXG | Class II | 2018-03-24 |
| K170410 | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | GXN | Class II | 2018-03-23 |
| K173571 | Element System with IBT Electrodes | Infinite Biomedical Technologies, LLC | GXY | Class II | 2018-03-21 |
| K173358 | ARTAS System | Restoration Robotics, Inc. | ONA | Class II | 2018-03-16 |
| K180421 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | OMB | Class II | 2018-03-14 |
| K173628 | Acclarent ENT Navigation System | Acclarent, Inc. | PGW | Class II | 2018-03-10 |
| K173682 | L300 Go System | Bioness, Inc. | GZI | Class II | 2018-03-09 |
| K173690 | Grass TWin | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | OLV | Class II | 2018-03-09 |
| K172115 | Navigated Instrument System | Orthofix, Inc. | OLO | Class II | 2018-03-08 |
| K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) | Bayer Healthcare, LLC | NUH | Class II | 2018-03-07 |
| K172820 | Microscope Navigation Software | Brainlab AG | HAW | Class II | 2018-03-01 |
| K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | OAN | Class II | 2018-03-01 |
| K173186 | S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D | Everyway Medical Instruments Co.,Ltd | GXY | Class II | 2018-02-28 |
| K173763 | iovera system | Myoscience, Inc. | GXH | Class II | 2018-02-28 |
| K172042 | NeuroNav System, NeuroSmart System | Alpha Omega Engineering , Ltd. | GZL | Class II | 2018-02-27 |
| K180181 | Natus Quantum | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) | GWQ | Class II | 2018-02-22 |
| K172390 | Optima Coil System | Blockade Medical, LLC (D.B.A. Balt Usa) | HCG | Class II | 2018-02-18 |
| K173460 | NeuroEEG | Memory MD, Inc. | GWQ | Class II | 2018-02-16 |
| K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) | Concentric Medical, Inc. | POL | Class II | 2018-02-15 |
| K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | GXH | Class II | 2018-02-15 |
| K171384 | Micromed BRAIN QUICK system | Micromed S.P.A. | GWQ | Class II | 2018-02-01 |
| K171396 | ODFS Pace XL | Odstock Medical, Ltd. | GZI | Class II | 2018-01-31 |
| K172935 | Embrace | Empatica S.r.l. | POS | Class II | 2018-01-26 |
| K172890 | SedLine Sedation Monitor | Masimo Corporation | OLW | Class II | 2018-01-26 |
| K173442 | gammaCore-S | Electrocore, LLC | PKR | Class II | 2018-01-23 |
| K173338 | Navigated INFINITY Instruments | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2018-01-18 |
| K171556 | K2M Navigation Instruments | K2m | OLO | Class II | 2018-01-16 |
| K171722 | Electrodes with snap / Electrodes with pigtail | Shenzhen Konmed Technology Co., Ltd. | GXY | Class II | 2018-01-10 |
| K172858 | PreOp | Epilog | OLX | Class II | 2018-01-08 |
| K172518 | Spineology Navigation Instruments | Spineology, Inc. | OLO | Class II | 2018-01-05 |
| K171721 | Electrodes with silver conductive | Shenzhen Konmed Technology Co., Ltd. | GXY | Class II | 2018-01-05 |
| K170138 | NEURONAUTE | Bioserenity | GWQ | Class II | 2017-12-26 |
| K171581 | Neuro Omega System | Alpha Omega Engineering , Ltd. | GZL | Class II | 2017-12-22 |
| K172978 | SurgeoBite | Surgovations, LLC | JXL | Class II | 2017-12-22 |
| K171102 | Ives MR Conditional Cup Electrode | Ives Egg Solutions | GXY | Class II | 2017-12-21 |
| K172623 | NuVasive Navigation Instruments | Nu Vasive, Incorporated | OLO | Class II | 2017-12-21 |
| K163550 | Pobling MIITY 2 | Habalan Med & Beauty Co.,Ltd | NFO | Class II | 2017-12-20 |
| K172986 | Zmachine Synergy | Consolidated Research of Richmond, Inc. Dba General Sleep CO | OLV | Class II | 2017-12-19 |
| K171381 | Adhesive Electrodes | Shenzhen Quality Medical Technology Co.,Ltd | GXY | Class II | 2017-12-13 |
| K171781 | eVox System | Evoke Neuroscience, Inc. | GWQ | Class II | 2017-12-13 |
| K173441 | Neurosoft TMS (also CloudTMS) | Teleemg, LLC | OBP | Class II | 2017-12-13 |
| K173462 | Wireless Pain Relieve Device Model: LT5018C | Shenzhen Dongdixin Technology Co., Ltd. | NUH | Class II | 2017-12-08 |
6,130 clearances in the Neurology panel. Data: openFDA.