Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 41
- Latest Decision
- 2020-06-12
Clearances · page 13 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K201022 | REAL INTELLIGENCE CORI (CORI) | Blue Belt Technologies, Inc. | OLO | Class II | 2020-06-12 |
| K193094 | Naviswiss Hip Navigation System | Naviswiss AG | OLO | Class II | 2020-06-10 |
| K201255 | TSolution® One Total Knee Application | THINK Surgical, Inc. | OLO | Class II | 2020-06-10 |
| K201175 | StealthStation Cranial Software v1.3.0 | Medtronic Navigation, Inc. | HAW | Class II | 2020-06-03 |
| K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | GXR | Class II | 2020-06-03 |
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | Pro Med Instruments GmbH | HBL | Class II | 2020-06-02 |
| K193307 | HIP7 | Brainlab AG | OLO | Class II | 2020-06-02 |
| K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | Conmed Corporation | GXY | Class II | 2020-06-01 |
| K200511 | ROSA ONE Brain application | Medtech S.A | HAW | Class II | 2020-05-29 |
| K201189 | Stealthstation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc. | OLO | Class II | 2020-05-29 |
| K200984 | Guardian Needle Electrode | Rhythmlink International, LLC | GXZ | Class II | 2020-05-27 |
| K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level | Medtronic, Inc. | GWM | Class II | 2020-05-26 |
| K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | OMB | Class II | 2020-05-18 |
| K190118 | Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) | Guangzhou Xinbo Electronic Co., Ltd. | GXY | Class II | 2020-05-13 |
| K200935 | Mazor X | Mazor Robotics , Ltd. | OLO | Class II | 2020-05-08 |
| K200950 | Ventricular Catheter | Aesculap, Inc. | JXG | Class II | 2020-05-08 |
| K183110 | LIVIA | Lifecare , Ltd. | NUH | Class II | 2020-05-04 |
| K200807 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Inc. | JXG | Class II | 2020-04-29 |
| K192834 | MECTA Sigma | Mecta Corporation | QGH | Class II | 2020-04-26 |
| K192068 | i-ED COIL | Kaneka Pharma America, LLC | HCG | Class II | 2020-04-25 |
| K191492 | Maxxi Position Sensor | Neurovirtual USA, Inc. | GWQ | Class II | 2020-04-24 |
| K193033 | GSI Audera Pro | Grason Stadler | GWJ | Class II | 2020-04-24 |
| K200705 | Nurochek System | Cryptych Pty, Ltd. | GWE | Class II | 2020-04-23 |
| K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Wuhan Greentek Pty , Ltd. | GXY | Class II | 2020-04-21 |
| K200665 | VERASENSE for Stryker Triathlon | Orthosensor, Inc. | ONN | Class II | 2020-04-12 |
| K200642 | OrthAlign Plus System | Orthalign, Inc. | OLO | Class II | 2020-04-10 |
| K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | Medtronic, Inc. | GWM | Class II | 2020-04-09 |
| K191422 | Neural Navigator | Soterix Medical, Inc. | HAW | Class II | 2020-04-06 |
| K193580 | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left | Orthosensor, Inc. | ONN | Class II | 2020-04-01 |
| K191868 | iCEWav Neuromonitoring Platform | Ice Neurosystems, Inc. | GWQ | Class II | 2020-03-31 |
| K200482 | StimRouter Neuromodulation System | Bioness, Inc. | GZF | Class II | 2020-03-27 |
| K200456 | Becker External Drainage and Monitoring System | Medtronic, Inc. | GWM | Class II | 2020-03-26 |
| K191830 | gammaCore Sapphire | Electrocore, Inc. | PKR | Class II | 2020-03-26 |
| K191716 | Somryst | Pear Therapeutics, Inc. | QVO | Class II | 2020-03-23 |
| K193453 | TruDi Probe | Acclarent, Inc. | PGW | Class II | 2020-03-23 |
| K192753 | NeuralScan System | Medeia, Inc. | GWQ | Class II | 2020-03-17 |
| K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited | NUH | Class II | 2020-03-14 |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | Neurovention, LLC | GXR | Class II | 2020-03-13 |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Fiagon GmbH | PGW | Class II | 2020-03-10 |
| K200262 | L100 Go System | Bioness, Inc. | GZI | Class II | 2020-03-04 |
| K192491 | Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. | GXD | Class II | 2020-02-21 |
| K191740 | DORO LUCENT® iXI and iMRI Headrest System | Pro Med Instruments GmbH | HBL | Class II | 2020-02-21 |
| K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | PGW | Class II | 2020-02-21 |
| K192624 | ApneaTrak | Cadwell Industries, Inc. | OLV | Class II | 2020-02-20 |
| K191785 | Orion LifeSpan MEG | Compumedics Limited | OLY | Class II | 2020-02-14 |
| K193120 | Real Intelligence Cori | Blue Belt Technologies, Inc. | OLO | Class II | 2020-02-14 |
| K193502 | TGS Universal Headrest with Mounting Arm | Stryker Ent | PGW | Class II | 2020-02-14 |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | Blackrock Microsystems | GYC | Class II | 2020-02-14 |
| K200079 | ClearPoint System and Accessories | Mri Interventions, Inc. | HAW | Class II | 2020-02-13 |
| K191975 | Elefix V Paste for EEG & EMG | Nihon Kohden Corporation | GYB | Class II | 2020-02-07 |
| K190259 | Vesta RF Cannula | Biomerics | GXI | Class II | 2020-02-07 |
| K200117 | Trevo NXT ProVue Retriever | Stryker | POL | Class II | 2020-02-07 |
| K193128 | Mako Total Hip Application | Mako Surgical Corp. | OLO | Class II | 2020-02-02 |
| K200030 | Optima Coil System | Balt USA, LLC | HCG | Class II | 2020-02-01 |
| K192397 | TruDi Navigation System | Biosense Webster | PGW | Class II | 2020-01-30 |
| K192889 | Neo | Eemagine Medical Imaging Solutions GmbH | OMA | Class II | 2020-01-30 |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode | Ad-Tech Medical Instrument Corporation | GYC | Class II | 2020-01-25 |
| K191293 | LCCS VC-S RF Cannula | Lccs Products Limited | GXI | Class II | 2020-01-24 |
| K191432 | cortiQ PRO | G.Tec Medical Engineering GmbH | OLU | Class II | 2020-01-24 |
| K191322 | E-EEGX, N-EEGX | GE Healthcare Finland Oy | OLT | Class II | 2020-01-22 |
| K192564 | Disposable Gold Cup EEG Electrodes | Dymedix Diagnostics, Inc. | GXY | Class II | 2020-01-21 |
| K192495 | Black Diamond Navigation Instruments | Osseus Fusion Systems | OLO | Class II | 2020-01-17 |
| K193547 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | GXN | Class II | 2020-01-17 |
| K192606 | SAC2 - Electrode Cream | Spes Medica Srl | GYB | Class II | 2020-01-17 |
| K191210 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | GXN | Class II | 2020-01-09 |
| K191739 | Sterile LeadConfirm | Alpha Omega Engineering , Ltd. | GZL | Class II | 2020-01-02 |
| K190929 | xvision Spine system (XVS) | Augmedics, Ltd. | SBF | Class II | 2019-12-20 |
| K190881 | Spinal Elements Navigated Instruments | Spinal Elements, Inc. | OLO | Class II | 2019-12-19 |
| K192589 | Everyway OTC TENS/EMS Combination | Everyway Medical Instruments Co.,Ltd | NUH | Class II | 2019-12-19 |
| K192572 | CNS Envision | Moberg Research, Inc. | OLT | Class II | 2019-12-17 |
| K182731 | Corelink Navigation Instruments | Corelink, LLC | OLO | Class II | 2019-12-13 |
| K190673 | Health Expert Electronic Stimulator | Shenzhen Osto Technology Company Limited | NUH | Class II | 2019-12-12 |
| K193135 | TSolution One Total Knee Application | THINK Surgical, Inc. | OLO | Class II | 2019-12-11 |
| K191700 | EyeStat | Blinktbi, Inc. | GZP | Class II | 2019-12-09 |
| K191861 | Aurora Surgiscope System | Rebound Therapeutics | GWG | Class II | 2019-12-06 |
| K192773 | ALLIVE | Nu Eyne Co., Ltd. | PCC | Class II | 2019-12-06 |
| K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) | Hong Qiangxing (Shenzhen) Electronics Limited | NUH | Class II | 2019-12-02 |
| K191722 | Vital Navigation System | Zimmer Biomet Spine, Inc. | OLO | Class II | 2019-12-02 |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph | Neurolign USA, LLC | GWN | Class II | 2019-11-29 |
| K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical, Inc. | HAW | Class II | 2019-11-27 |
| K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | GWO | Class II | 2019-11-27 |
| K192764 | NeuroOne Cortical Electrode | Neuroone, Inc. | GYC | Class II | 2019-11-26 |
| K190760 | Cadwell Bolt Software | Cadwell Industries, Inc. | OLT | Class II | 2019-11-23 |
| K192207 | Trevo NXT ProVue Retriever | Stryker | POL | Class II | 2019-11-22 |
| K191075 | Healy | Timewaver Production GmbH | NUH | Class II | 2019-11-22 |
| K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2019-11-22 |
| K192603 | Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | GXZ | Class II | 2019-11-22 |
| K192266 | M. Blue Adjustable Shunt System | Aesculap, Inc. | JXG | Class II | 2019-11-21 |
| K192955 | Penumbra LP Coil System | Penumbra, Inc. | HCG | Class II | 2019-11-20 |
| K191701 | Arcus Head Fixation Frame | Mri Interventions, Inc. | HBL | Class II | 2019-11-15 |
| K192289 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Ltd. | JXG | Class II | 2019-11-15 |
| K192911 | Brainlab Compatible K2M Navigation Instruments | K2m, Inc. | OLO | Class II | 2019-11-14 |
| K192469 | Nox Sleep System | Nox Medical | OLZ | Class II | 2019-11-13 |
| K191466 | SandShark Injectable Anchor (SIA) System | Stimwave Technologies, Inc. | GZB | Class II | 2019-11-07 |
| K192080 | iASSIST Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | 2019-11-05 |
| K192140 | 7D Surgical System | 7D Surgical, Inc. | OLO | Class II | 2019-11-05 |
| K192087 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | NUH | Class II | 2019-11-01 |
| K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | HAW | Class II | 2019-11-01 |
| K190047 | StimRouter Neuromodulation System | Bioness, Inc. | GZF | Class II | 2019-10-31 |
| K192133 | Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. | OLO | Class II | 2019-10-29 |
6,130 clearances in the Neurology panel. Data: openFDA.