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
4755 Neurology devices
3926–3950 of 4755
Cleared Dec 05, 1994
ELECTROFLEX
K943126 · Medical Devices, Inc.
GXY · Electrode, Cutaneous · 159d
Cleared Nov 22, 1994
CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR
K942413 · Clarus Medical Systems, Inc.
GWG · Endoscope, Neurological · 186d
Cleared Nov 21, 1994
INSIGHT ELECTRONIC ALIGNMENT INDICATOR
K940812 · Andronic Devices, Ltd.
KQX · Goniometer, Ac-powered · 272d
Cleared Nov 07, 1994
PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS)
K935560 · Pmt Corp.
JXG · Shunt, Central Nervous System And Components · 355d
Cleared Nov 04, 1994
CLARUS NEUROPEN MODEL 2120
K942249 · Clarus Medical Systems, Inc.
GWG · Endoscope, Neurological · 179d
Cleared Oct 21, 1994
ELECTRODE, CUTANEOUS
K933801 · Cadwell Laboratories, Inc.
GXY · Electrode, Cutaneous · 443d
Cleared Oct 04, 1994
NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE
K932059 · Dantec Medical, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 523d
Cleared Sep 26, 1994
DANTEC 13R45 BAR ELECTRODE
K934580 · Dantec Medical, Inc.
GXY · Electrode, Cutaneous · 368d
Cleared Sep 07, 1994
CUTANEOUS ELECTRODE
K933802 · Cadwell Laboratories, Inc.
GXY · Electrode, Cutaneous · 399d
Cleared Aug 25, 1994
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
K931029 · Chalgren Enterprises, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 542d
Cleared Aug 03, 1994
DISPOSABLE BIPOLAR ELECTRODE
K942955 · Neuro Navigational Corp.
GWG · Endoscope, Neurological · 41d
Cleared Jul 29, 1994
THERATOUCH 4.7
K932868 · Rich-Mar Corp.
LIH · Interferential Current Therapy · 410d
Cleared Jul 27, 1994
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116 · United States Surgical, A Division of Tyco Healthc
HAE · Rongeur, Manual · 30d
Cleared Jul 26, 1994
GROUND PLATE ELECTRODE
K933807 · Cadwell Laboratories, Inc.
GXY · Electrode, Cutaneous · 356d
Cleared Jul 25, 1994
AUTO SUTURE PITUITARY SPINAL RONGEUR
K943115 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 28d
Cleared Jul 20, 1994
CORDIS GRAVITY COMPENSATING ACCESSORY
K932429 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 426d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL CURETTE
K942967 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL OSTEOTOME
K942968 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL NERVE HOOK
K942969 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL ELEVATOR
K942970 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL DISSECTOR
K942971 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 30d
Cleared Jul 18, 1994
NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
K940416 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 171d
Cleared Jul 11, 1994
BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
K934051 · Skylark Device Co., Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 326d
Cleared Jul 11, 1994
NEUROLOGICAL LEAD ACCESSORIES
K936099 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 201d
Cleared Jul 11, 1994
AESCULAP NEUROENDOSCOPE
K941239 · Aesculap, Inc.
GWG · Endoscope, Neurological · 118d

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All categories 4755 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 308 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 284 JXG Shunt, Central Nervous System And Components 224 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 142 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 101 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67