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
1726–1750 of 1755
Cleared Feb 05, 1980
MEDTRONIC PISCES GENERATION II LEAD KIT
K800193 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 7d
Cleared Dec 31, 1979
HALO SUPPORT JACKET & ASSOC. HARDWARE
K792586 · Depuy, Inc.
HAX · Tong, Skull For Traction · 14d
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 May 31, 1979
T.E.N.S.* SINGLE-USE ELECTRODE
K790850 · 3M Company
GXY · Electrode, Cutaneous · 27d
Cleared May 25, 1979
PISCES-SELECTOR X
K790790 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 31d
Cleared Feb 07, 1979
MEDTRONIC MODEL 3797 ELECTRODE
K782137 · Medtronic Vascular
GXY · Electrode, Cutaneous · 42d
Cleared Dec 14, 1978
STIMULATOR, MODEL 7727
K782075 · Medtronic Vascular
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 1d
Cleared Jun 28, 1978
ELECTROENCEPHALOGRAPH ACCUTRATE 200
K781005 · Beckman Instruments, Inc.
GWQ · Full-montage Standard Electroencephalograph · 9d
Cleared Jun 28, 1978
ELECTROENCEPHALOGRAPH ACCUTRACE 100
K781041 · Beckman Instruments, Inc.
GWQ · Full-montage Standard Electroencephalograph · 8d
Cleared May 19, 1978
SUBCUPASS TUNNELING TOOL
K780579 · Medtronic Vascular
HAO · Instrument, Surgical, Non-powered · 39d
Cleared May 19, 1978
NEUROLOGICAL SCREENING STIMULATOR M 3623
K780758 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 11d
Cleared Mar 02, 1978
NEUROMOD STIMULATOR MODEL 3723
K780186 · Medtronic Vascular
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 24d
Cleared Feb 23, 1978
TRACTION UNITS
K780228 · Biomet, Inc.
HST · Apparatus, Traction, Non-powered · 14d
Cleared Feb 23, 1978
TRACTION WEIGHT BAGS
K780233 · Biomet, Inc.
HST · Apparatus, Traction, Non-powered · 14d
Cleared Jan 17, 1978
EPIDURAL LEAD - MODEL 3481
K780001 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 18d
Cleared Jan 06, 1978
AESTHESIOMETER
K772406 · Fred Sammons, Inc.
GXB · Esthesiometer · 10d
Cleared Jan 05, 1978
PINCH GUAGE
K772413 · Fred Sammons, Inc.
HRW · Dynamometer, Nonpowered · 9d
Cleared Jan 05, 1978
DYNAMETER 50 LB.
K772415 · Fred Sammons, Inc.
HRW · Dynamometer, Nonpowered · 9d
Cleared Jan 03, 1978
CATHETER, INTRACRANIAL PRESS. MONITOR.
K772063 · Cordis Corp.
GWM · Device, Monitoring, Intracranial Pressure · 62d
Cleared Oct 28, 1977
PERCUPASS TUNNELING TOOL MODEL 3452
K772013 · Medtronic Vascular
HAO · Instrument, Surgical, Non-powered · 3d
Cleared Aug 16, 1977
PERITONEAL INTRODUCER & SHEATH
K771529 · Cordis Corp.
GYK · Instrument, Shunt System Implantation · 8d
Cleared Jul 21, 1977
JAMAR DYNAMOMETEO BK-7498
K771288 · Fred Sammons, Inc.
HRW · Dynamometer, Nonpowered · 38d
Cleared Dec 21, 1976
G.E. TELEMETRY MONITORING
K761259 · General Electric Co.
GYE · Encephalogram Telemetry System · 6d

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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