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
1576–1600 of 1755
Cleared Feb 03, 1998
MEDTRONIC MODEL 3998 LEAD
K971756 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 267d
Cleared Jan 16, 1998
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
K972332 · Aesculap, Inc.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 207d
Cleared Jan 09, 1998
CODMAN INTRACRANIAL BOLT
K974088 · Johnson & Johnson Professionals, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 71d
Cleared Dec 29, 1997
CODMAN HAKIM MICRO PRECISION VALVE
K973774 · Johnson & Johnson Professionals, Inc.
JXG · Shunt, Central Nervous System And Components · 87d
Cleared Dec 09, 1997
LYOPLANT DURA SUBSTITUTE(VARIOUS)
K970851 · Aesculap, Inc.
GXQ · Dura Substitute · 277d
Cleared Nov 26, 1997
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
K970050 · Aesculap, Inc.
HCH · Clip, Aneurysm · 324d
Cleared Aug 22, 1997
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
K972043 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 81d
Cleared Jul 03, 1997
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
K964172 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 258d
Cleared Jun 25, 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923 · Johnson & Johnson Professionals, Inc.
JXG · Shunt, Central Nervous System And Components · 198d
Cleared Apr 21, 1997
AESCULAP ANGLED NEUROENDOSCOPES
K964281 · Aesculap, Inc.
GWG · Endoscope, Neurological · 175d
Cleared Dec 20, 1996
CORDIS SHARP-ENDED STYLET
K955265 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 402d
Cleared Nov 19, 1996
BIFURCATED Y-EXTENSION
K953742 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 469d
Cleared Oct 25, 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 288d
Cleared May 21, 1996
MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX
K960631 · Medtronic Vascular
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 97d
Cleared May 17, 1996
DUALSCREEN
K955291 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 183d
Cleared May 10, 1996
NEURO-PATCH
K960470 · Aesculap, Inc.
GXQ · Dura Substitute · 99d
Cleared Mar 25, 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
K955832 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 90d
Cleared Mar 07, 1996
AESCULAP VENTRICULOSCOPE SYSTEM
K954394 · Aesculap, Inc.
GWG · Endoscope, Neurological · 171d
Cleared Dec 06, 1995
BRAY RONGEUR
K954699 · Johnson & Johnson Professionals, Inc.
HAE · Rongeur, Manual · 55d
Cleared Nov 27, 1995
MODEL NOS. 7495 AND 501826 EXTENSIONS
K954886 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 151d
Cleared Oct 26, 1995
COMAN(R) CU-11 MODEL NUMBER 82-6634
K945585 · Johnson & Johnson Professionals, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 346d
Cleared Oct 24, 1995
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
K954021 · Johnson & Johnson Professionals, Inc.
JXG · Shunt, Central Nervous System And Components · 85d
Cleared Oct 19, 1995
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
K944595 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 395d
Cleared Oct 03, 1995
NONPOWERED NEUROSURGICAL INSTRUMENT
K953173 · United States Surgical, A Division of Tyco Healthc
GWG · Endoscope, Neurological · 88d
Cleared Aug 30, 1995
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
K952459 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 96d

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All categories 1755 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 121 HAW Neurological Stereotaxic Instrument 93 QJP Catheter, Percutaneous, Neurovasculature 91 GXY Electrode, Cutaneous 90 JXG Shunt, Central Nervous System And Components 73 NRY Catheter, Thrombus Retriever 73 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 71 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 49 OBP Transcranial Magnetic Stimulator 48 HCG Device, Neurovascular Embolization 41 GWG Endoscope, Neurological 39 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 38 DQY Catheter, Percutaneous 36 MOF Guide, Wire, Catheter, Neurovasculature 29 GWQ Full-montage Standard Electroencephalograph 27