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

6235

Total

6180

Cleared

154d

Avg (2y)

1976

Since

1755 Neurology devices

1676–1700 of 1755

Cleared Oct 06, 1987

MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD

K873675 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 22d

Cleared Jul 21, 1987

MEDTENS(TM), MODEL NUMBER 7725

K871722 · Medtronic Vascular

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

Cleared Feb 26, 1987

ECLIPSE+, MODEL NUMBER 7723

K865048 · Medtronic Vascular

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 64d

Cleared Feb 20, 1987

CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.

K863469 · Cordis Corp.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 165d

Cleared Jan 20, 1987

TENZCARE(TM) SNAP ELECTRODE 6867

K864973 · 3M Company

GXY · Electrode, Cutaneous · 32d

Cleared Sep 23, 1986

TENZCARE SNAP ELECTRODE, NO. 6865

K863307 · 3M Company

GXY · Electrode, Cutaneous · 29d

Cleared Aug 25, 1986

MICRA MICROSURGICAL INSTRUMENTS

K862971 · Cordis Corp.

GZX · Instrument, Microsurgical · 19d

Cleared Aug 01, 1986

EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS

K862513 · Cordis Corp.

JXG · Shunt, Central Nervous System And Components · 31d

Cleared Jun 19, 1986

STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES

K861377 · Cordis Corp.

JXG · Shunt, Central Nervous System And Components · 66d

Cleared May 09, 1986

MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT

K855107 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 137d

Cleared Jan 10, 1986

EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID

K855058 · Cordis Corp.

JXG · Shunt, Central Nervous System And Components · 23d

Cleared Dec 27, 1985

INTRACRANIAL PRESSURE MONITORING CUP CATHETERS

K854657 · Cordis Corp.

GWM · Device, Monitoring, Intracranial Pressure · 37d

Cleared Nov 27, 1985

EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE

K854474 · Cordis Corp.

JXG · Shunt, Central Nervous System And Components · 20d

Cleared Aug 14, 1985

CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A

K852827 · Cordis Corp.

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 43d

Cleared Jun 04, 1985

K851063 · Intermedics, Inc.

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

Cleared May 23, 1985

COMFORT-EASE ELECTRODE

K851303 · Medtronic Vascular

GXY · Electrode, Cutaneous · 52d

Cleared Feb 06, 1985

MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL

K844115 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 106d

Cleared Feb 04, 1985

K844098 · Medtronic Vascular

GXY · Electrode, Cutaneous · 104d

Cleared Jan 24, 1985

INTERCEPTOR, 662-01

K844279 · Intermedics, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 80d

Cleared Dec 11, 1984

CANMED 103 9300 ELECTRODE

K844097 · Medtronic Vascular

GXY · Electrode, Cutaneous · 49d

Cleared May 14, 1984

MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL

K841584 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 27d

Cleared Mar 19, 1984

SPINAL CORD STIMULATION SYS SE-4

K833990 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 119d

Cleared Jan 30, 1984

HYPAL ADHESIVE TAPE

K832991 · Smith & Nephew, Inc.

KQX · Goniometer, Ac-powered · 150d

Cleared Aug 31, 1983

NEUROMOD COMFORT WAVE #7721 DUAL-

K832238 · Medtronic Vascular

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 51d

Cleared Aug 11, 1983

PISCES #3487 EPIDURAL LEAD FOR SPINAL

K831746 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 71d

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