FDA Review Panel · NE

FDA 510(k) Neurology Devices

FDA 510(k) Neurology Devices - Regulatory Overview

FDA 510(k) neurology devices cover diagnostic and therapeutic equipment for the nervous system. The FDA review panel code is NE.

Common categories include:

  • EEG and neurophysiology systems - electroencephalographs, EMG, nerve conduction
  • Neurostimulators - transcranial magnetic stimulation (TMS), vagus nerve stimulation
  • Surgical navigation systems - image-guided neurosurgery platforms
  • Intracranial pressure monitors - ICP sensors and drainage systems
  • Neuroendoscopes - rigid and flexible scopes for minimally invasive neurosurgery

6291
Total
6236
Cleared
153d
Avg (2y)
1976
Since
4715 Neurology devices
1676–1700 of 4715
Cleared Dec 08, 2016
Stryker Universal Mesh
K161821 · Stryker
GWO · Plate, Cranioplasty, Preformed, Alterable · 160d
Cleared Dec 06, 2016
CRW STEREOTACTIC SYSTEM
K160811 · Integra LifeSciences Corporation
HAW · Neurological Stereotaxic Instrument · 257d
Cleared Dec 05, 2016
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
K161453 · Well-Life Healthcare Limited
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 193d
Cleared Dec 01, 2016
Phasor Drill
K161704 · Biotex, Inc.
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 164d
Cleared Dec 01, 2016
RemLogic
K162140 · Embla Systems
OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph · 122d
Cleared Nov 21, 2016
Electronic Pulse Stimulator
K160508 · Beijing Choice Electronic Technololgy Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 271d
Cleared Nov 10, 2016
Solitaire 2 Revascularization Device
K162539 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
POL · Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment · 59d
Cleared Nov 08, 2016
Cadwell AmpliScan
K161027 · Cadwell Industries, Inc.
OMA · Amplitude-integrated Electroencephalograph · 210d
Cleared Nov 04, 2016
Trex_HD
K162595 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
GWQ · Full-montage Standard Electroencephalograph · 50d
Cleared Nov 02, 2016
Durepair Dura Regeneration Matrix
K161370 · Medtronic Neurosurgery
GXQ · Dura Substitute · 169d
Cleared Oct 31, 2016
AxoGuard Nerve Connector
K162741 · Cook Biotech Incorporated
JXI · Cuff, Nerve · 31d
Cleared Oct 30, 2016
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
K161282 · Medico Electrodes International , Ltd.
GXY · Electrode, Cutaneous · 177d
Cleared Oct 28, 2016
Codman EDS3 CSF External Drainage System
K162437 · Codman & Shurtleff, Inc.
JXG · Shunt, Central Nervous System And Components · 58d
Cleared Oct 27, 2016
Smart External Drain (SED) System
K161605 · Aqueduct Critical Care, Inc.
JXG · Shunt, Central Nervous System And Components · 139d
Cleared Oct 20, 2016
HICP200 Patient/Monitor Interconnect Cable
K161010 · Innerspace Neuro Solutions, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 192d
Cleared Oct 19, 2016
TENS Electrodes
K160081 · Cathay Manufacturing Corp.
GXY · Electrode, Cutaneous · 278d
Cleared Oct 18, 2016
Neuromonitoring Kit
K161893 · SI-BONE, Inc.
PDQ · Neurosurgical Nerve Locator · 99d
Cleared Oct 14, 2016
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
K161912 · Asahi Intecc Co., Ltd.
MOF · Guide, Wire, Catheter, Neurovasculature · 94d
Cleared Oct 13, 2016
OTC TENS Device, Model PTS-IV
K161537 · Counter Scientific Development (Gz), Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 132d
Cleared Oct 06, 2016
SimulCare II(TM)
K160246 · Xanacare Technologies, LLC
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 248d
Cleared Oct 05, 2016
Painmaster MCT Patch
K151995 · Newmark, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 443d
Cleared Sep 30, 2016
Traxcess .007 Mini Guidewire
K161803 · MicroVention, Inc.
MOF · Guide, Wire, Catheter, Neurovasculature · 92d
Cleared Sep 27, 2016
Biopor Porous Polyethylene Implants
K161446 · Ceremed , Inc.
GWO · Plate, Cranioplasty, Preformed, Alterable · 125d
Cleared Sep 23, 2016
VSP Cranial System
K151285 · 3D Systems, Inc.
PPT · Cranial Surgical Planning And Instrument Guides · 498d
Cleared Sep 22, 2016
Ahead 300
K161068 · Brainscope Company, Inc.
PIW · Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid · 160d

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All categories 4715 HAW Neurological Stereotaxic Instrument 341 GXY Electrode, Cutaneous 305 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 276 JXG Shunt, Central Nervous System And Components 222 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 140 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 100 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 86 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67