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
3901–3925 of 4755
Cleared Apr 24, 1995
MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE
K946318 · Physiometrix, Inc.
GXY · Electrode, Cutaneous · 117d
Cleared Apr 19, 1995
TECOTHANE 55D
K950425 · Medtronic Vascular
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 76d
Cleared Apr 12, 1995
MODEL 3470 X-TREL RF RECEIVER
K943537 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 264d
Cleared Apr 05, 1995
PREMIER PROMAX BITE GUARD
K941856 · Premier Dental Products Co.
JXL · Block, Bite · 355d
Cleared Mar 30, 1995
CAMINO VENTRICULAR DRAINAGE SYSTEM
K932769 · Camino Laboratories, Inc.
JXG · Shunt, Central Nervous System And Components · 660d
Cleared Mar 29, 1995
RICH-MAR CARBON ELECTRODES
K950491 · Rich-Mar Corp.
GXY · Electrode, Cutaneous · 51d
Cleared Mar 16, 1995
FORTE ES
K940759 · Chattanooga Group, Inc.
GZI · Stimulator, Neuromuscular, External Functional · 391d
Cleared Mar 10, 1995
SUNDT SLIM-LINE GRAFT CLIPS
K912456 · Codman & Shurtleff, Inc.
HCH · Clip, Aneurysm · 1376d
Cleared Mar 01, 1995
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · Cordis Corp.
GWM · Device, Monitoring, Intracranial Pressure · 379d
Cleared Feb 21, 1995
DISPOSABLE ASPIRATION/IRRIGATION CATHETER
K934154 · Neuro Navigational Corp.
GWG · Endoscope, Neurological · 543d
Cleared Feb 21, 1995
CUTANEOUS ELECTRODE
K941986 · Maxxim Medical
GXY · Electrode, Cutaneous · 302d
Cleared Feb 14, 1995
MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
K934065 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 543d
Cleared Feb 03, 1995
DISPOSABLE CUTANEOUS ELECTRODES
K941799 · Bio-Logic Systems Corp.
GXY · Electrode, Cutaneous · 297d
Cleared Feb 03, 1995
VARIOUS ELECTRODES
K941928 · Bio-Logic Systems Corp.
GWN · Nystagmograph · 289d
Cleared Feb 03, 1995
CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352
K945572 · Johnson & Johnson Professionals, Inc.
GWG · Endoscope, Neurological · 81d
Cleared Jan 30, 1995
ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
K950127 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 18d
Cleared Jan 24, 1995
YASARGIL, CASPAR, VARIO CLIP APPLIERS
K940970 · Aesculap, Inc.
HCI · Applier, Aneurysm Clip · 328d
Cleared Jan 20, 1995
CUEVA CRANIAL NERVE ELECTRODE
K944061 · Ad-Tech Medical Instrument Corp
GZL · Electrode, Depth · 154d
Cleared Jan 11, 1995
TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
K945103 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 85d
Cleared Dec 29, 1994
EEG NEEDLE ELECTRODE
K933796 · Cadwell Laboratories, Inc.
GXZ · Electrode, Needle · 512d
Cleared Dec 29, 1994
EEG CUP ELECTRODE
K933808 · Cadwell Laboratories, Inc.
GXY · Electrode, Cutaneous · 512d
Cleared Dec 19, 1994
RING ELECTRODE
K933805 · Cadwell Laboratories, Inc.
GXY · Electrode, Cutaneous · 502d
Cleared Dec 15, 1994
CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS
K944603 · Conmedcorp
GXY · Electrode, Cutaneous · 87d
Cleared Dec 13, 1994
CONTOUR EMBOLI
K944354 · Interventional Therapeutics Corp.
HCG · Device, Neurovascular Embolization · 105d
Cleared Dec 05, 1994
SMARTBRACE ELECTRODE
K940012 · Medical Devices, Inc.
GXY · Electrode, Cutaneous · 335d

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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