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
4751 Neurology devices
3526–3550 of 4751
Cleared Aug 14, 1998
GB-1002 TENS WITH MASSAGE
K964437 · Skylark Device Co., Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 647d
Cleared Aug 14, 1998
CAROLINE GUIDE
K981809 · Surgical Solutions, Inc.
HAW · Neurological Stereotaxic Instrument · 85d
Cleared Aug 07, 1998
STEALTHSTATION SYSTEM DIGITIZER CHANGE
K981686 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 86d
Cleared Aug 07, 1998
POS T-7000
K981805 · Pos Technologies, Inc.
HCS · Device, Temperature Measurement, Direct Contact, Powered · 78d
Cleared Aug 07, 1998
SLEEP MANAGEMENT SYSTEM
K981844 · Rmp, Inc.
HCC · Device, Biofeedback · 73d
Cleared Aug 06, 1998
IMAGE VUE EEG
K980477 · Sam Technology, Inc.
OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph · 181d
Cleared Aug 06, 1998
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K981684 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 85d
Cleared Aug 05, 1998
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K982364 · Radionics, Inc.
HAW · Neurological Stereotaxic Instrument · 30d
Cleared Jul 30, 1998
DURA-GUARD - DURAL REPAIR PATCH
K982282 · Bio-Vascular, Inc.
GXQ · Dura Substitute · 30d
Cleared Jul 29, 1998
OLYMPUS NEURO ENDOSCOPE
K971340 · Olympus Optical, Co.
GWG · Endoscope, Neurological · 475d
Cleared Jul 29, 1998
MICRO II MICROCURRENT TENS
K973978 · Apex Medical Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 282d
Cleared Jul 29, 1998
MULTI-STIM TENS, AP-101081T
K973979 · Apex Medical Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 282d
Cleared Jul 29, 1998
ACU-STIM TENS, AP-101082T
K973980 · Apex Medical Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 282d
Cleared Jul 29, 1998
LUNA
K982351 · Stellate Systems
OLT · Non-normalizing Quantitative Electroencephalograph Software · 23d
Cleared Jul 17, 1998
BMC RF CANNULA
K972846 · Baylis Medical Co., Inc.
GXI · Probe, Radiofrequency Lesion · 350d
Cleared Jul 17, 1998
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778 · Johnson & Johnson Professionals, Inc.
JXG · Shunt, Central Nervous System And Components · 137d
Cleared Jul 17, 1998
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
K981730 · Nk Biotechnical Corp.
LBB · Dynamometer, Ac-powered · 63d
Cleared Jul 16, 1998
SYNERGY LT
K981405 · Oxford Instruments, Plc.
GWF · Stimulator, Electrical, Evoked Response · 87d
Cleared Jul 10, 1998
NEUROMETRIC ANALYSIS SYSTEM
K974748 · Nxlink, Ltd.
OLU · Normalizing Quantitative Electroencephalograph Software · 203d
Cleared Jul 09, 1998
TAKA ANEURYSM CLIP
K972750 · V. Mueller Neuro/Spine
HCH · Clip, Aneurysm · 351d
Cleared Jul 09, 1998
NAVITRACK
K981315 · Orthosoft, Inc.
HAW · Neurological Stereotaxic Instrument · 90d
Cleared Jul 06, 1998
SEVRAIN CRANIAL CLAMP
K971252 · Ikonos Corp.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 459d
Cleared Jul 01, 1998
HAKIM PROGRAMMABLE VALVE SYSTEM
K974739 · Johnson & Johnson Professionals, Inc.
JXG · Shunt, Central Nervous System And Components · 194d
Cleared Jul 01, 1998
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I
K981213 · Radionics, Inc.
HAW · Neurological Stereotaxic Instrument · 90d
Cleared Jun 16, 1998
PALI-TRODE
K981015 · Preferred Instruments
GZL · Electrode, Depth · 90d

Looking for a specific neurology device? Search by device name, K-number or manufacturer.

Search all Neurology 510(k) devices

Filter by Product Code

All categories 4751 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 281 JXG Shunt, Central Nervous System And Components 224 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 142 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 101 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67