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

4763 Neurology devices

4126–4150 of 4763

Cleared Jul 17, 1991

SWIVEL HORSESHOE HEADREST

K911918 · Codman & Shurtleff, Inc.

HBM · Headrest, Neurosurgical · 78d

Cleared Jul 16, 1991

VERSA-STIM ELECTRODE LINE MODIFIED

K911069 · Conmedcorp

GXY · Electrode, Cutaneous · 127d

Cleared Jun 28, 1991

NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300

K905594 · Nihon Kohden America, Inc.

GWK · Conditioner, Signal, Physiological · 197d

Cleared Jun 28, 1991

PS MEDICAL BUTTON VALVE

K911410 · Pudenz-Schulte Medical Research Corp.

JXG · Shunt, Central Nervous System And Components · 88d

Cleared Jun 27, 1991

ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A

K905569 · Biomedical Life Systems, Inc.

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 197d

Cleared Jun 24, 1991

SX90 (TM),MODEL 4800S

K912348 · Medical Devices, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 27d

Cleared Jun 04, 1991

ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A

K905230 · Biomedical Life Systems, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 196d

Cleared Jun 04, 1991

ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A

K905377 · Biomedical Life Systems, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 186d

Cleared Jun 04, 1991

ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A

K905570 · Biomedical Life Systems, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 174d

Cleared May 28, 1991

3M 6830 ELECTRODE

K905539 · 3M Healthcare

GXY · Electrode, Cutaneous · 168d

Cleared May 14, 1991

DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)

K902607 · Dantec Medical, Inc.

GWF · Stimulator, Electrical, Evoked Response · 336d

Cleared May 08, 1991

ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A

K905571 · Biomedical Life Systems, Inc.

LIH · Interferential Current Therapy · 147d

Cleared Apr 24, 1991

GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET

K910853 · Cordis Corp.

JXG · Shunt, Central Nervous System And Components · 55d

Cleared Apr 10, 1991

MENTOR EEG SYSTEM

K904763 · Oxford Medilog, Inc.

GWQ · Full-montage Standard Electroencephalograph · 170d

Cleared Apr 08, 1991

MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR

K901540 · Radionics, Inc.

GXD · Generator, Lesion, Radiofrequency · 371d

Cleared Mar 27, 1991

MC II (TM), MODEL 7200S

K903161 · Medical Devices, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 252d

Cleared Mar 19, 1991

EEG-5400 SERIES

K902550 · Nihon Kohden America, Inc.

GWQ · Full-montage Standard Electroencephalograph · 286d

Cleared Mar 15, 1991

DYNATRON 200 MICROCURRENT

K903577 · Dynatronics Corp.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 219d

Cleared Feb 21, 1991

CODMAN DISPOSABLE SCALP CLIP APPLIER

K905433 · Codman & Shurtleff, Inc.

HBO · Clip, Scalp · 79d

Cleared Feb 19, 1991

K900723 · Interventional Therapeutics Corp.

HCG · Device, Neurovascular Embolization · 369d

Cleared Feb 14, 1991

MEDTRONIC (R) MODEL 3625 SCREENER

K903690 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 183d

Cleared Feb 12, 1991

FLEXCOMP DSP & PROCOMP

K903497 · Thought Technology , Ltd.

HCC · Device, Biofeedback · 193d

Cleared Feb 11, 1991

MEDTRONIC MODEL 3487A PISCES-QUAD LEAD

K910199 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 26d

Cleared Feb 04, 1991

SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME

K903731 · Teca, Inc.

GWF · Stimulator, Electrical, Evoked Response · 172d

Cleared Feb 01, 1991

MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME

K905407 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 60d

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