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
4774 Neurology devices
4676–4700 of 4774
Cleared Feb 05, 1980
MEDTRONIC PISCES GENERATION II LEAD KIT
K800193 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 7d
Cleared Jan 31, 1980
TELEMETRY SYSTEM XMT-1 & REC-1
K792371 · Burdick Corp.
GYE · Encephalogram Telemetry System · 66d
Cleared Jan 31, 1980
H-H FIFTH VENTRICLE
K800168 · Holter-Hausner Intl.
JXG · Shunt, Central Nervous System And Components · 6d
Cleared Jan 16, 1980
CSF-CARDIAC/PERITONEAL CATHETER
K792005 · Pudenz-Schulte Medical Research Corp.
JXG · Shunt, Central Nervous System And Components · 103d
Cleared Jan 16, 1980
CSF-VENTRICULAR CATHETER, STANDARD DES
K792007 · Pudenz-Schulte Medical Research Corp.
JXG · Shunt, Central Nervous System And Components · 103d
Cleared Jan 04, 1980
CMS 6000
K792380 · Physio-Control Corp.
GYE · Encephalogram Telemetry System · 39d
Cleared Dec 31, 1979
HALO SUPPORT JACKET & ASSOC. HARDWARE
K792586 · Depuy, Inc.
HAX · Tong, Skull For Traction · 14d
Cleared Dec 31, 1979
H-H SHUNT INTRODUCER
K792639 · Holter-Hausner Intl.
GYK · Instrument, Shunt System Implantation · 11d
Cleared Dec 13, 1979
MODEL 980D TENS NEUROPACER
K792522 · Empi
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 7d
Cleared Dec 05, 1979
MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE
K792351 · Medtronic Vascular
GXY · Electrode, Cutaneous · 16d
Cleared Nov 21, 1979
MEDTRONIC BURR HOLE PLUG & CAP
K792206 · Medtronic Vascular
· 23d
Cleared Nov 21, 1979
MEDTRONIC MODEL 7728 NEUROMOD
K792311 · Medtronic Vascular
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 5d
Cleared Oct 01, 1979
SCOVILLE-LEWIS ANEURYSM CLIPS
K791764 · Codman & Shurtleff, Inc.
HCH · Clip, Aneurysm · 34d
Cleared Sep 28, 1979
SUGITA ANEURYSM CLIPS, APPLIERS & CASE
K791978 · Codman & Shurtleff, Inc.
Cleared Sep 17, 1979
SPECTRA R PAD
K791013 · Parker Laboratories, Inc.
GYB · Media, Electroconductive · 108d
Cleared Sep 17, 1979
STIMULATOR MODEL SSS-1101
K791149 · Nihon Kohden America, Inc.
GWE · Stimulator, Photic, Evoked Response · 94d
Cleared Sep 12, 1979
ELECTROENCEPHALOGRAPHS MODELS 7209,7213
K791150 · Nihon Kohden America, Inc.
GWQ · Full-montage Standard Electroencephalograph · 89d
Cleared Sep 12, 1979
MODEL EEG-4214 ELECTROENCEPHALOGRAPH
K791233 · Nihon Kohden America, Inc.
GWQ · Full-montage Standard Electroencephalograph · 75d
Cleared Sep 12, 1979
MODEL EEG-4217 ELECTROENCEPHALOGRAPH
K791234 · Nihon Kohden America, Inc.
GWQ · Full-montage Standard Electroencephalograph · 75d
Cleared Sep 04, 1979
CEREBRAL FUNCTION MONITOR 870
K791580 · Applied Medical Research
OMA · Amplitude-integrated Electroencephalograph · 18d
Cleared Aug 28, 1979
DISPOSABLE PERFORATORS, JACOBS, HUDSON
K791101 · Codman & Shurtleff, Inc.
HBF · Drills, Burrs, Trephines & Accessories (compound, Powered) · 76d
Cleared Aug 16, 1979
CADWELL 7000 ELECTROMYOGRAPH MACHINE
K791235 · Cadwell Laboratories, Inc.
IKN · Electromyograph, Diagnostic · 41d
Cleared Aug 03, 1979
INTRACRANIAL PRESSURE MONITORING
K790920 · Codman & Shurtleff, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 86d
Cleared Aug 03, 1979
H-H SLOTTED CATHETER-RESERVOIR
K791075 · Holter-Hausner Intl.
JXG · Shunt, Central Nervous System And Components · 52d
Cleared Aug 03, 1979
H-H SLOTTED VENTRICULAR CATHETER
K791076 · Holter-Hausner Intl.
JXG · Shunt, Central Nervous System And Components · 52d

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All categories 4774 HAW Neurological Stereotaxic Instrument 345 GXY Electrode, Cutaneous 312 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 286 JXG Shunt, Central Nervous System And Components 224 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 212 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 143 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 102 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 72 OBP Transcranial Magnetic Stimulator 68