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
4755 Neurology devices
3951–3975 of 4755
Cleared Jul 08, 1994
DISPOSABLE TAB ELECTRODE
K933803 · Cadwell Laboratories, Inc.
GXY · Electrode, Cutaneous · 338d
Cleared Jul 06, 1994
ALICE
K922106 · Healthdyne, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 792d
Cleared Jun 30, 1994
CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE
K936101 · Conmedcorp
GXY · Electrode, Cutaneous · 190d
Cleared Jun 22, 1994
CONMED VERSA-STIM INTERFERENTIAL ELECTRODE
K940704 · Conmedcorp
GXY · Electrode, Cutaneous · 126d
Cleared Jun 14, 1994
IF400
K930535 · Skylark Device Co., Ltd.
LIH · Interferential Current Therapy · 497d
Cleared Jun 14, 1994
TEMPORARY SCREENING LEAD/CATHETER KIT
K934938 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 239d
Cleared Jun 09, 1994
STAT-TENS
K931079 · Skylark Device Co., Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 463d
Cleared May 27, 1994
TEN-20 CONDUCTIVE PASTE GEL
K933799 · Cadwell Laboratories, Inc.
GYB · Media, Electroconductive · 296d
Cleared May 26, 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935324 · Chattanooga Group, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 202d
Cleared May 17, 1994
OMNI PREP GEL
K933797 · Cadwell Laboratories, Inc.
GYB · Media, Electroconductive · 286d
Cleared May 04, 1994
MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT
K932202 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 363d
Cleared May 03, 1994
PS MEDICAL CATHETER PLACEMENT KIT
K940096 · Pudenz-Schulte Medical Research Corp.
GWG · Endoscope, Neurological · 116d
Cleared Apr 28, 1994
PS MEDICAL DELTA BURR HOLE VALVE
K934545 · Pudenz-Schulte Medical Research Corp.
JXG · Shunt, Central Nervous System And Components · 218d
Cleared Apr 22, 1994
CONCENTRIC EMG NEEDLE ELECTRODE
K933795 · Cadwell Laboratories, Inc.
GXZ · Electrode, Needle · 261d
Cleared Apr 22, 1994
NU-PREP GEL
K933798 · Cadwell Laboratories, Inc.
GXB · Esthesiometer · 261d
Cleared Apr 22, 1994
MONOPOLAR EMG NEEDLE ELECTRODE
K933806 · Cadwell Laboratories, Inc.
GXZ · Electrode, Needle · 261d
Cleared Apr 19, 1994
GROUND/REFERENCE NEEDLE ELECTRODE
K933793 · Cadwell Laboratories, Inc.
GXZ · Electrode, Needle · 258d
Cleared Apr 12, 1994
CODMAN QUICK SHUNT KIT, CAT. #82-6570
K934196 · Codman & Shurtleff, Inc.
GWG · Endoscope, Neurological · 229d
Cleared Mar 30, 1994
DANTEC DISPOSABLE CONCENTRIC NEEDLE
K931966 · Dantec Medical, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 343d
Cleared Mar 22, 1994
CADWELL EASY WRITER AND EASY READER
K932407 · Cadwell Laboratories, Inc.
GWQ · Full-montage Standard Electroencephalograph · 308d
Cleared Mar 22, 1994
LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
K933804 · Cadwell Laboratories, Inc.
GYB · Media, Electroconductive · 230d
Cleared Mar 22, 1994
CERVICAL SELF-RETAINING RETRACTOR
K935529 · T. Korossurgical Instruments Corp.
GZT · Retractor, Self-retaining, For Neurosurgery · 126d
Cleared Mar 22, 1994
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
K936019 · Nomos Corp.
HAW · Neurological Stereotaxic Instrument · 95d
Cleared Mar 14, 1994
HOME MICROCURRENT HMC
K935132 · Medical Devices, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 137d
Cleared Mar 07, 1994
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479 · Codman & Shurtleff, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 881d

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All categories 4755 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 308 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 284 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