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
4760 Neurology devices
4076–4100 of 4760
Cleared Mar 25, 1992
MODEL 704
K912139 · Ivy Biomedical Systems, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 316d
Cleared Mar 16, 1992
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS
K912282 · Chalgren Enterprises, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 293d
Cleared Mar 16, 1992
DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K912283 · Chalgren Enterprises, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 298d
Cleared Mar 11, 1992
YASARGIL ANEURYSM CLIPS, MODIFICATION
K913765 · Aesculap, Inc.
HCH · Clip, Aneurysm · 202d
Cleared Mar 11, 1992
NEUROFAX EEG 5532
K915096 · Nihon Kohden America, Inc.
GWQ · Full-montage Standard Electroencephalograph · 120d
Cleared Mar 09, 1992
CORDIS STRAIGHT VENTRICULAR CATHETER
K914995 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 123d
Cleared Feb 26, 1992
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
K912685 · Nihon Kohden America, Inc.
GWF · Stimulator, Electrical, Evoked Response · 254d
Cleared Feb 19, 1992
CORDIS RIGHT-ANGLE CATHETER GUIDE
K913842 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 175d
Cleared Feb 14, 1992
ELECTRODE
K912643 · Skylark Device Co., Ltd.
GXY · Electrode, Cutaneous · 245d
Cleared Feb 07, 1992
MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS
K913993 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 154d
Cleared Jan 30, 1992
LOW BACK STRIP (OR) K-BACK
K912381 · Katecho, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 246d
Cleared Jan 30, 1992
K-STIM
K913031 · Katecho, Inc.
GXY · Electrode, Cutaneous · 205d
Cleared Jan 30, 1992
DANTEC COUNTERPOINT MK2(TM)
K913957 · Dantec Medical, Inc.
GWJ · Stimulator, Auditory, Evoked Response · 148d
Cleared Jan 22, 1992
MEDTRONIC MODEL 3586 RESUME LEAD
K913934 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 141d
Cleared Jan 22, 1992
MODEL 3587A RESUME II LEAD
K915540 · Medtronic Vascular
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 43d
Cleared Jan 17, 1992
VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
K914735 · Camino Laboratories, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 88d
Cleared Jan 15, 1992
AD-TECH EPIDURAL PEG ELECTRODE
K912760 · Ad-Tech Medical Instrument Corp
GYC · Electrode, Cortical · 205d
Cleared Jan 14, 1992
ELECTRODE USING PROMEON RG-60 SERIES GEL
K915333 · Labeltape Meditect, Inc.
GXY · Electrode, Cutaneous · 49d
Cleared Dec 30, 1991
PS MEDICAL VENTRICULOSTOMY KIT
K915546 · Pudenz-Schulte Medical Research Corp.
HBG · Drills, Burrs, Trephines & Accessories (manual) · 19d
Cleared Dec 23, 1991
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
K914433 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 80d
Cleared Dec 18, 1991
TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
K914871 · Labeltape Meditect, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 50d
Cleared Dec 12, 1991
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
K913636 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 119d
Cleared Dec 10, 1991
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 222d
Cleared Nov 22, 1991
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
K912764 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 151d
Cleared Nov 22, 1991
MEDTRONIC 3625 SCREENER SYSTEM
K913442 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 112d

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All categories 4760 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 309 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 285 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 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 67