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
4767 Neurology devices
4376–4400 of 4767
Cleared Sep 24, 1986
RAYLOR BONE IMPACTORS
K863415 · Cedar Surgical, Inc.
HAO · Instrument, Surgical, Non-powered · 21d
Cleared Sep 24, 1986
RAYLOR MINI-PROBE
K863416 · Cedar Surgical, Inc.
HAO · Instrument, Surgical, Non-powered · 21d
Cleared Sep 23, 1986
TENZCARE SNAP ELECTRODE, NO. 6865
K863307 · 3M Company
GXY · Electrode, Cutaneous · 29d
Cleared Sep 18, 1986
POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER
K863035 · Valleylab, Inc.
GXY · Electrode, Cutaneous · 38d
Cleared Sep 17, 1986
40-HZ AUDITORY EVOKED RESPONSE TEST
K862361 · Cadwell Laboratories, Inc.
GWJ · Stimulator, Auditory, Evoked Response · 86d
Cleared Sep 17, 1986
INSERT EARPHONES
K862363 · Cadwell Laboratories, Inc.
GWJ · Stimulator, Auditory, Evoked Response · 86d
Cleared Sep 09, 1986
VERSA STIM
K862718 · Conmedcorp
GXY · Electrode, Cutaneous · 54d
Cleared Aug 27, 1986
EMPI, MODEL 1000 HAND HELD ELECTRODE
K862231 · Empi
GXY · Electrode, Cutaneous · 77d
Cleared Aug 25, 1986
WYLER SPHENOIDAL ELECTRODE
K861031 · Ad-Tech Medical Instrument Corp
GZL · Electrode, Depth · 160d
Cleared Aug 25, 1986
MICRA MICROSURGICAL INSTRUMENTS
K862971 · Cordis Corp.
GZX · Instrument, Microsurgical · 19d
Cleared Aug 20, 1986
OEE_7102 EEG/TREND MONITOR
K854662 · Nihon Kohden America, Inc.
GWS · Analyzer, Spectrum, Electroencephalogram Signal · 273d
Cleared Aug 20, 1986
NEUROFAX 7310 SERIES (EEG)
K854663 · Nihon Kohden America, Inc.
GWQ · Full-montage Standard Electroencephalograph · 273d
Cleared Aug 18, 1986
ULTRAPAC II SD (TM)
K862337 · Medical Devices, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 59d
Cleared Aug 14, 1986
MEB-5200
K854664 · Nihon Kohden America, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 267d
Cleared Aug 12, 1986
ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.
K860458 · Oxford Medilog, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 188d
Cleared Aug 12, 1986
KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
K861629 · Downs Surgical , Ltd.
HAW · Neurological Stereotaxic Instrument · 105d
Cleared Aug 12, 1986
CAMINO CSF DRAINAGE SYSTEM MODEL 040
K861961 · Camino Laboratories, Inc.
JXG · Shunt, Central Nervous System And Components · 84d
Cleared Aug 12, 1986
BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.
K862303 · Pudenz-Schulte Medical Research Corp.
JXG · Shunt, Central Nervous System And Components · 56d
Cleared Aug 11, 1986
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
K860456 · Oxford Medilog, Inc.
GWQ · Full-montage Standard Electroencephalograph · 187d
Cleared Aug 01, 1986
ULTRAHESIVE II POSTOP ELECTRODE
K862028 · Medical Devices, Inc.
GXY · Electrode, Cutaneous · 65d
Cleared Aug 01, 1986
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
K862513 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 31d
Cleared Jul 18, 1986
CAMINO HAND DRILL - MODEL 030
K862160 · Camino Laboratories, Inc.
HBG · Drills, Burrs, Trephines & Accessories (manual) · 42d
Cleared Jul 15, 1986
EMPI MODEL GLS 450, TENS
K861830 · Empi
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 63d
Cleared Jul 11, 1986
MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
K861822 · Valley Forge Scientific Corp.
GWO · Plate, Cranioplasty, Preformed, Alterable · 60d
Cleared Jul 03, 1986
EMPI MODEL 720 NMS, TENS
K861451 · Empi
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 76d

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All categories 4767 HAW Neurological Stereotaxic Instrument 343 GXY Electrode, Cutaneous 311 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 286 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 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