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

4750 Neurology devices

3451–3475 of 4750

Cleared Apr 12, 1999

TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR

K990129 · Therapy Link, Inc.

LIH · Interferential Current Therapy · 89d

Cleared Apr 12, 1999

MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)

K990370 · Msb,Uk

GXY · Electrode, Cutaneous · 63d

Cleared Apr 01, 1999

CRX WORLD SHUNT

K990256 · Phoenix Biomedical Corp.

JXG · Shunt, Central Nervous System And Components · 64d

Cleared Mar 30, 1999

VIEWPOINT MICROSCOPE OPTION

K990860 · Philips Medical Systems (Cleveland), Inc.

HAW · Neurological Stereotaxic Instrument · 14d

Cleared Mar 30, 1999

VIEWPOINT PASSIVE TOOL OPTION

K990868 · Philips Medical Systems (Cleveland), Inc.

HAW · Neurological Stereotaxic Instrument · 14d

Cleared Mar 24, 1999

VASCULAR OCCLUSION SYSTEM

K983483 · Cordis Neurovascular, Inc.

HCG · Device, Neurovascular Embolization · 170d

Cleared Mar 23, 1999

OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM

K983229 · Olympic Medical Corp.

OMA · Amplitude-integrated Electroencephalograph · 189d

Cleared Mar 23, 1999

K983533 · Mini-Mitter Co., Inc.

GWQ · Full-montage Standard Electroencephalograph · 166d

Cleared Mar 22, 1999

K983007 · Neuroregen, LLC

JXI · Cuff, Nerve · 206d

Cleared Mar 15, 1999

BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000

K983228 · Murray Electronics

NYN · Stimulator, Electrical, Transcutaneous, For Arthritis · 181d

Cleared Mar 15, 1999

BACK-ON-TRAC, MODEL 101BOT

K984190 · Back-On-Track, Inc.

HST · Apparatus, Traction, Non-powered · 112d

Cleared Mar 15, 1999

PRECLUDE ACUSEAL DURA SUBSTITUTE

K984534 · W.L. Gore & Associates, Inc.

GXQ · Dura Substitute · 84d

Cleared Mar 15, 1999

THE BIOPLATE SHUNT CONNECTOR

K984583 · Biomedics

JXG · Shunt, Central Nervous System And Components · 81d

Cleared Mar 12, 1999

K984580 · Biosys AB (Publ)

OLV · Standard Polysomnograph With Electroencephalograph · 79d

Cleared Mar 11, 1999

K982173 · Mwr Electronics Industrial Co.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 265d

Cleared Mar 09, 1999

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25

K990375 · Medtronic Functional Diagnostics A/S

IKT · Electrode, Needle, Diagnostic Electromyograph · 29d

Cleared Mar 04, 1999

OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII

K990326 · Radionics Software Applications, Inc.

HAW · Neurological Stereotaxic Instrument · 30d

Cleared Feb 23, 1999

RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R

K982967 · Woodside Biomedical, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 182d

Cleared Feb 18, 1999

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM

K980689 · Friddle'S Orthopedic Appliances, Inc.

HAX · Tong, Skull For Traction · 360d

Cleared Feb 12, 1999

TRAJECTORY GUIDE, MODEL # TGX-XXX

K983539 · Image-Guided Neurologics, Inc.

HAW · Neurological Stereotaxic Instrument · 126d

Cleared Feb 12, 1999

AESCULAP AXIAL CLIP APPLIER

K984109 · Aesculap, Inc.

HCI · Applier, Aneurysm Clip · 87d

Cleared Feb 10, 1999

K984025 · Care Rehab, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 90d

Cleared Feb 09, 1999

MEDTRONIC MODEL 7495 EXTENSION KIT

K990104 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 28d

Cleared Feb 04, 1999

BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM

K984053 · Medtronic PS Medical

JXG · Shunt, Central Nervous System And Components · 90d

Cleared Feb 01, 1999

VECTRA STIM MODELS 200 AND 400

K982321 · Chattanooga Group, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 214d

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