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
4701–4725 of 4774
Cleared Jun 05, 1979
MEDI-TRACE EEG CREME
K790818 · Graphic Controls Corp.
GYB · Media, Electroconductive · 39d
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 May 23, 1979
STIMULATOR, NIC-106 VISUAL
K790570 · Nicolet Biomedical Instruments
GWE · Stimulator, Photic, Evoked Response · 61d
Cleared May 11, 1979
H-H FIXATION AND JOINING CONNECTORS
K790849 · Holter-Hausner Intl.
JXG · Shunt, Central Nervous System And Components · 8d
Cleared May 01, 1979
OCTAGONAL ALUMINUM FRAMING SYSTEM
K790729 · Orthopedic Systems, Inc.
HST · Apparatus, Traction, Non-powered · 19d
Cleared Apr 23, 1979
MODEL 1309 AUDIO MONITOR
K790664 · Life-Tech Instruments, Inc.
IKN · Electromyograph, Diagnostic · 17d
Cleared Apr 17, 1979
EEG GEL
K781493 · Graphic Controls Corp.
GYB · Media, Electroconductive · 232d
Cleared Apr 05, 1979
DYONICS STEROTOXIC POSITIONER
K790502 · Dyonics, Inc.
HAW · Neurological Stereotaxic Instrument · 23d
Cleared Mar 27, 1979
ELECTRODE, ELECTROFLEX
K790316 · Andover Medical, Inc.
GXY · Electrode, Cutaneous · 40d
Cleared Mar 21, 1979
CREAM, SIGNA
K782055 · Parker Laboratories, Inc.
GYB · Media, Electroconductive · 100d
Cleared Mar 16, 1979
HEIFETZ ANEURYSM CLIP, LMM BLADE
K790413 · Edward Weck, Inc.
HCH · Clip, Aneurysm · 18d
Cleared Mar 08, 1979
STIMULATOR, MODEL 1-600 ELECTRIC NERVR
K782164 · Ipco Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 76d
Cleared Mar 02, 1979
STIMULATOR, MENTOR 100 NERVE
K790011 · Mentor Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 59d
Cleared Feb 07, 1979
MEDTRONIC MODEL 3797 ELECTRODE
K782137 · Medtronic Vascular
GXY · Electrode, Cutaneous · 42d
Cleared Jan 26, 1979
VALVE, H-H CRUCIFORM SLIT
K790126 · Holter-Hausner Intl.
JXG · Shunt, Central Nervous System And Components · 2d
Cleared Jan 15, 1979
CATHETERS, H-H VENTRICULAR
K782105 · Holter-Hausner Intl.
JXG · Shunt, Central Nervous System And Components · 27d
Cleared Dec 14, 1978
STIMULATOR, MODEL 7727
K782075 · Medtronic Vascular
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 1d
Cleared Nov 22, 1978
NEUROPAC ULTRA II
K781829 · Medical Devices, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 23d
Cleared Nov 14, 1978
CATHETERS, H-H ATRIAL AND PERITONEAL
K781768 · Holter-Hausner Intl.
JXG · Shunt, Central Nervous System And Components · 29d
Cleared Nov 08, 1978
MODEL 7320 VISUAL STIMULATOR
K781461 · Life-Tech Instruments, Inc.
GWE · Stimulator, Photic, Evoked Response · 82d
Cleared Oct 31, 1978
EEG LEAD ASSEMBLY
K781494 · Graphic Controls Corp.
GXY · Electrode, Cutaneous · 64d
Cleared Sep 20, 1978
TECA MODEL B9 ELECTROMYOGRAPH
K781399 · Teca, Inc.
IKN · Electromyograph, Diagnostic · 36d
Cleared Sep 07, 1978
ELECTRODE IMPEDANCE TESTER-MODEL 500
K781475 · Life-Tech Instruments, Inc.
GYA · Tester, Electrode/lead, Electroencephalograph · 10d
Cleared Aug 31, 1978
ACCESSORY TO 4-24 RECORDER
K781129 · Oxford Medilog, Inc.
GWQ · Full-montage Standard Electroencephalograph · 57d

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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