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

4760 Neurology devices

4051–4075 of 4760

Cleared Oct 15, 1992

SD-605 SD II PROGRAM

K923935 · Skylark Device Co., Ltd.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 71d

Cleared Oct 13, 1992

K920260 · Chattanooga Group, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 266d

Cleared Oct 13, 1992

MICRO 100,200,300, & 400 TENS

K923298 · Skylark Device Co., Ltd.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 99d

Cleared Oct 06, 1992

K921679 · Katecho, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 181d

Cleared Oct 05, 1992

REUSABLE DUAL DISC BAR RECORDING ELECTRODES

K923665 · Chalgren Enterprises, Inc.

JXE · Device, Nerve Conduction Velocity Measurement · 75d

Cleared Sep 22, 1992

K921828 · Henley Intl.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 159d

Cleared Sep 22, 1992

K922020 · Henley Intl.

LIH · Interferential Current Therapy · 145d

Cleared Sep 15, 1992

YASARGIL ANEURYSM CLIPS

K922272 · Aesculap, Inc.

HCH · Clip, Aneurysm · 124d

Cleared Sep 11, 1992

REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS

K921504 · Chalgren Enterprises, Inc.

JXE · Device, Nerve Conduction Velocity Measurement · 164d

Cleared Sep 09, 1992

K915858 · Thought Technology , Ltd.

HCC · Device, Biofeedback · 257d

Cleared Sep 09, 1992

MYOTRAC/S, MYODAC/S

K915859 · Thought Technology , Ltd.

HCC · Device, Biofeedback · 257d

Cleared Aug 26, 1992

K921953 · Excel Tech. , Ltd.

LIH · Interferential Current Therapy · 121d

Cleared Aug 26, 1992

K921954 · Excel Tech. , Ltd.

LIH · Interferential Current Therapy · 121d

Cleared Aug 17, 1992

NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE

K915530 · American Threshold Industries, Inc.

HAX · Tong, Skull For Traction · 251d

Cleared Aug 14, 1992

BIO-DETEK EEG ELECTRODE

K920352 · Bio-Detek, Inc.

GXZ · Electrode, Needle · 200d

Cleared Aug 10, 1992

SPINE MOTION ANALYZER WITH EMG

K920256 · Orthopedic Systems, Inc.

KQX · Goniometer, Ac-powered · 202d

Cleared Jul 29, 1992

ITC BUNJI COIL (MODIFICATION)

K920324 · Interventional Therapeutics Corp.

HCG · Device, Neurovascular Embolization · 187d

Cleared Jul 07, 1992

MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS

K921558 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 97d

Cleared Jun 10, 1992

JANUS ATAC ENG ANALYSIS SYSTEM

K904385 · Life-Tech Intl., Inc.

GWN · Nystagmograph · 625d

Cleared Jun 02, 1992

BIO-DETEK TRACERITE EEG ELECTRODE

K920264 · Bio-Detek, Inc.

GXY · Electrode, Cutaneous · 133d

Cleared May 20, 1992

MODELS 3987 AND 3988 RESUME LEAD FOR PNS

K920567 · Medtronic Vascular

GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 103d

Cleared May 08, 1992

INTERFERENTIAL STIMULATOR MODEL INF 4150/A

K921441 · Biomedical Life Systems, Inc.

LIH · Interferential Current Therapy · 44d

Cleared May 04, 1992

ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A

K915210 · Biomedical Life Systems, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 168d

Cleared May 01, 1992

CAMINO VENTRICULAR NEEDLE

K920088 · Camino Laboratories, Inc.

HCD · Cannula, Ventricular · 114d

Cleared Mar 26, 1992

MYOTRAC+/S, MYODAC+/S

K913898 · Thought Technology , Ltd.

HCC · Device, Biofeedback · 209d

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