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
4753 Neurology devices
3751–3775 of 4753
Cleared Nov 15, 1996
M & R DISPOSABLE ELECTRODE (14200)
K963236 · M & R Mfg., Inc.
GXY · Electrode, Cutaneous · 88d
Cleared Nov 08, 1996
PHILIPS EASYGUIDE NEURO
K961834 · Philips Medical Systems, Inc.
HAW · Neurological Stereotaxic Instrument · 179d
Cleared Oct 31, 1996
MRS-2D
K961645 · Lexicor Medical Technology, Inc.
HCC · Device, Biofeedback · 185d
Cleared Oct 31, 1996
NEUROMAG-122
K962764 · Philips Medical Systems (Cleveland), Inc.
OLY · Magnetoencephalograph · 107d
Cleared Oct 25, 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 288d
Cleared Oct 25, 1996
STEALTHSTATION SYSTEM
K963173 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 72d
Cleared Oct 23, 1996
OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]
K961844 · Radionics Software Applications, Inc.
HAW · Neurological Stereotaxic Instrument · 163d
Cleared Oct 23, 1996
RADIONICS SIPHON LIMITING DEVICE (SLD)
K962990 · Radionics, Inc.
JXG · Shunt, Central Nervous System And Components · 83d
Cleared Oct 22, 1996
ACTION POTENTIAL SIMULATION THERAPY DEVICE
K955470 · Neurotech, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 327d
Cleared Oct 17, 1996
SPETZLER TI 100 ANEURYSM CLIP
K955064 · Elekta Instruments, Inc.
HCH · Clip, Aneurysm · 346d
Cleared Oct 11, 1996
REIGEL TUNNELING DEVICE
K962761 · Cook, Inc.
GYK · Instrument, Shunt System Implantation · 87d
Cleared Oct 08, 1996
PERNECZKY CLIP APPLIER/REMOVER
K954658 · Von Zeppelin GmbH
HCI · Applier, Aneurysm Clip · 364d
Cleared Oct 08, 1996
A-1000 EEG MONITOR AND A-1050 EEG MONITOR
K963644 · Aspect Medical Systems, Inc.
OLW · Index-generating Electroencephalograph Software · 26d
Cleared Oct 04, 1996
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
K961821 · Aspect Medical Systems, Inc.
GXY · Electrode, Cutaneous · 147d
Cleared Oct 04, 1996
ECOGEL 300 TENS GEL
K962681 · Eco-Med Pharmaceuticals, Inc.
GYB · Media, Electroconductive · 86d
Cleared Sep 20, 1996
ECLIPSE VERSION 3.0
K955577 · Stellate Systems
OLT · Non-normalizing Quantitative Electroencephalograph Software · 317d
Cleared Sep 20, 1996
GUGLIELMI DETACHABLE COIL
K962503 · Target Therapeutics
HCG · Device, Neurovascular Embolization · 85d
Cleared Sep 18, 1996
SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M
K960754 · Mecta Corp.
QGH · Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder · 208d
Cleared Sep 12, 1996
MIZUHO RADIOLUCENT HEAD FRAME
K955012 · Mizuho America, Inc.
HBL · Holder, Head, Neurosurgical (skull Clamp) · 316d
Cleared Sep 12, 1996
SMART-TENS, MODEL 456
K961376 · Bio-Medical Research, Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 157d
Cleared Sep 05, 1996
DYNATRON 525
K961261 · Dynatronics Corp.
LIH · Interferential Current Therapy · 156d
Cleared Sep 05, 1996
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
K962910 · Uni-Patch, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 62d
Cleared Sep 03, 1996
3D-SPINE
K962377 · Skill Technologies, Inc.
KQX · Goniometer, Ac-powered · 75d
Cleared Aug 29, 1996
VENTRICULAR CATHETER SET
K962097 · Cook, Inc.
JXG · Shunt, Central Nervous System And Components · 92d
Cleared Aug 27, 1996
PHOENIX CRX VALVE
K960435 · Phoenix Biomedical Corp.
JXG · Shunt, Central Nervous System And Components · 209d

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All categories 4753 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 283 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