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
3651–3675 of 4751
Cleared Jul 22, 1997
BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000
K971437 · Murray Electronics
NYN · Stimulator, Electrical, Transcutaneous, For Arthritis · 95d
Cleared Jul 15, 1997
VISUALEYES: VIDEO EYE MONITOR
K964325 · Micromedical Technologies, Inc.
GWN · Nystagmograph · 258d
Cleared Jul 15, 1997
VIDEO EYE TRAKKER
K964646 · Micromedical Technologies, Inc.
GWN · Nystagmograph · 237d
Cleared Jul 14, 1997
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
K963208 · Neurotron Medical
JXE · Device, Nerve Conduction Velocity Measurement · 332d
Cleared Jul 14, 1997
GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE
K971395 · Target Therapeutics
DQX · Wire, Guide, Catheter · 90d
Cleared Jul 14, 1997
SNT STEREOTACTIC LOCALIZATION SYSTEM
K971675 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 68d
Cleared Jul 10, 1997
SOMNITOR 32K SLEEP ACTIVITY MONITOR
K965079 · Neurim Pharmaceuticals, Ltd.
LEL · Device, Sleep Assessment · 203d
Cleared Jul 10, 1997
MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
K970051 · Smith and Nephew Donjoy, Inc.
HCC · Device, Biofeedback · 184d
Cleared Jul 09, 1997
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
K971079 · Interlogics, Inc.
KQX · Goniometer, Ac-powered · 106d
Cleared Jul 03, 1997
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
K964172 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 258d
Cleared Jun 25, 1997
MODEL ME 300 MUSCLE TESTER
K943535 · Regulatory Strategies, Inc.
HCC · Device, Biofeedback · 1070d
Cleared Jun 25, 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923 · Johnson & Johnson Professionals, Inc.
JXG · Shunt, Central Nervous System And Components · 198d
Cleared Jun 25, 1997
SATELLITE
K971331 · Nicolet Biomedical, Inc.
GWQ · Full-montage Standard Electroencephalograph · 76d
Cleared Jun 20, 1997
SYNAPTIC 3000
K940954 · The Synaptic Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 1207d
Cleared Jun 20, 1997
TECA. MILLENNIUM
K965065 · Medelec , Ltd.
GWF · Stimulator, Electrical, Evoked Response · 184d
Cleared Jun 16, 1997
SNT DISPOSABLE BIOPSY NEEDLE
K971247 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 74d
Cleared Jun 13, 1997
PERITONEAL/CARDIAC CATHETER
K970983 · Integra Neurocare, LLC
JXG · Shunt, Central Nervous System And Components · 87d
Cleared Jun 04, 1997
RADIONICS BURR HOLE VALVE
K970578 · Radionics, Inc.
JXG · Shunt, Central Nervous System And Components · 110d
Cleared Jun 04, 1997
ISG FAMILY OF VIEWING WANDS
K970865 · I.S.G. Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 86d
Cleared Jun 02, 1997
OPTICAL TRACKING SYSTEM (OTS)
K964801 · Radionics Software Applications, Inc.
HAW · Neurological Stereotaxic Instrument · 185d
Cleared Jun 02, 1997
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM
K970942 · Physiometrix, Inc.
GWQ · Full-montage Standard Electroencephalograph · 80d
Cleared May 22, 1997
VECTORVISION
K962939 · Brainlab, Inc.
HAW · Neurological Stereotaxic Instrument · 297d
Cleared May 22, 1997
CRYSTAL-EEG MODEL 10 (MODEL 10)
K970672 · Cleveland Medical Devices, Inc.
OMC · Reduced- Montage Standard Electroencephalograph · 87d
Cleared May 19, 1997
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
K963202 · Mega Electronics , Ltd.
HCC · Device, Biofeedback · 277d
Cleared May 19, 1997
VIEWPOINT - 3.0 SOFTWARE
K970604 · Philips Medical Systems (Cleveland), Inc.
HAW · Neurological Stereotaxic Instrument · 90d

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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