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

4767 Neurology devices

4326–4350 of 4767

Cleared Jul 23, 1987

K872574 · Ferris Mfg. Corp.

GXY · Electrode, Cutaneous · 23d

Cleared Jul 21, 1987

MEDTENS(TM), MODEL NUMBER 7725

K871722 · Medtronic Vascular

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 78d

Cleared Jul 21, 1987

AMBULATORY EEG PLAYBACK

K872183 · Cadwell Laboratories, Inc.

GWQ · Full-montage Standard Electroencephalograph · 43d

Cleared Jul 16, 1987

NICOLET AMP 6R11 SYSTEM

K871678 · Nicolet Biomedical Instruments

GWL · Amplifier, Physiological Signal · 79d

Cleared Jul 16, 1987

CARBON ELECTRODE

K872044 · Futuremed Div. of Future Impex Corp.

GXY · Electrode, Cutaneous · 50d

Cleared Jul 15, 1987

CONDUCTIVITY GEL

K871913 · Futuremed Div. of Future Impex Corp.

GYB · Media, Electroconductive · 58d

Cleared Jul 15, 1987

CONDUCTIVITY GEL

K872045 · Futuremed Div. of Future Impex Corp.

GYB · Media, Electroconductive · 49d

Cleared Jul 10, 1987

ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER

K870773 · Hgm, Inc.

LLF · Laser, Neurosurgical, Argon · 134d

Cleared Jul 01, 1987

MODEL 5000 AMBULATORY MONITORING SYSTEM

K871500 · Oxford Medilog, Inc.

GWQ · Full-montage Standard Electroencephalograph · 76d

Cleared Jun 19, 1987

PMT TRACTION TONGS

K871663 · Progress Mankind Technology

HAX · Tong, Skull For Traction · 52d

Cleared Jun 18, 1987

K871571 · Ulster Scientific, Inc.

GXB · Esthesiometer · 57d

Cleared Jun 12, 1987

HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS

K871685 · American V. Mueller

JXG · Shunt, Central Nervous System And Components · 44d

Cleared Jun 02, 1987

ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN

K871125 · Biomedical Life Systems, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 74d

Cleared Jun 02, 1987

ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C

K871126 · Biomedical Life Systems, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 74d

Cleared May 22, 1987

RADIOPAQUE SPHERICAL EMBOLI (RSE)

K871047 · Interventional Therapeutics Corp.

HCG · Device, Neurovascular Embolization · 66d

Cleared May 22, 1987

CSF-CARDIAC/PERITONEAL CATHETER

K871752 · Pudenz-Schulte Medical Research Corp.

JXG · Shunt, Central Nervous System And Components · 14d

Cleared May 01, 1987

H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS

K870660 · Holter-Hausner Intl.

JXG · Shunt, Central Nervous System And Components · 71d

Cleared Apr 22, 1987

K870666 · Henley Intl.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 62d

Cleared Apr 22, 1987

K870667 · Henley Intl.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 62d

Cleared Apr 22, 1987

DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS

K871026 · Labeltape Meditect, Inc.

GXY · Electrode, Cutaneous · 37d

Cleared Apr 01, 1987

TENS DEVICE FOR RELIEF OF CHRONIC PAIN

K864114 · Futuremed Div. of Future Impex Corp.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 162d

Cleared Apr 01, 1987

EMPI LOGIX MODEL 712 NMS, TENS

K870168 · Empi

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 77d

Cleared Mar 13, 1987

BACPAC (TM), MODEL 6500

K864968 · Medical Devices, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 81d

Cleared Mar 13, 1987

EMG ELECTRODES AND EXTENSION CORDS

K870795 · Nihon Kohden America, Inc.

IKT · Electrode, Needle, Diagnostic Electromyograph · 15d

Cleared Mar 06, 1987

SELVERSTONE CLAMP SALIBI CLAMP

K870399 · Codman & Shurtleff, Inc.

HCE · Clamp, Carotid Artery · 32d

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

Search all Neurology 510(k) devices