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
4754 Neurology devices
3876–3900 of 4754
Cleared Sep 19, 1995
NEURO CHANNEL ENDOSCOPE MODEL 2232
K945633 · Clarus Medical Systems, Inc.
GWG · Endoscope, Neurological · 307d
Cleared Sep 18, 1995
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
K951258 · Pudenz-Schulte Medical Research Corp.
JXG · Shunt, Central Nervous System And Components · 181d
Cleared Sep 13, 1995
DYNATRON 650
K950348 · Dynatronics Corp.
LIH · Interferential Current Therapy · 229d
Cleared Sep 13, 1995
DYNATRON 950
K950349 · Dynatronics Corp.
LIH · Interferential Current Therapy · 229d
Cleared Sep 12, 1995
CADWELL EASY AMBULATORY EEG
K946094 · Cadwell Laboratories, Inc.
GWQ · Full-montage Standard Electroencephalograph · 272d
Cleared Sep 08, 1995
DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
K951256 · Target Therapeutics
HCG · Device, Neurovascular Embolization · 171d
Cleared Sep 01, 1995
DYNATRON 550
K941577 · Dynatronics Corp.
LIH · Interferential Current Therapy · 519d
Cleared Aug 30, 1995
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
K952459 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 96d
Cleared Aug 22, 1995
BIO-LOGIC AUTOMATIC EVENT ANALYSIS
K951594 · Bio-Logic Systems Corp.
OMB · Automatic Event Detection Software For Full-montage Electroencephalograph · 138d
Cleared Aug 15, 1995
ULTRACELL NEURO SPONGES
K950647 · Ultracell Medical Technologies, Inc.
HBA · Neurosurgical Paddie · 183d
Cleared Aug 11, 1995
RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE
K952089 · Rich-Mar Corp.
LIH · Interferential Current Therapy · 100d
Cleared Aug 08, 1995
TRUEFILL PVA PARTICLES
K951314 · Cordis Neurovascular, Inc.
HCG · Device, Neurovascular Embolization · 138d
Cleared Aug 04, 1995
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826 · Medical Device Inspection Co., Inc.
HCC · Device, Biofeedback · 248d
Cleared Jul 28, 1995
CODMAN-MEDOS VALVE SHUNT SYSTEM
K944222 · Johnson & Johnson Professionals, Inc.
JXG · Shunt, Central Nervous System And Components · 332d
Cleared Jul 14, 1995
CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160
K945296 · Clarus Medical Systems, Inc.
GWG · Endoscope, Neurological · 256d
Cleared Jul 14, 1995
1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES
K950154 · Neuro Navigational Corp.
GWG · Endoscope, Neurological · 178d
Cleared Jun 26, 1995
PGS123 AND HVS-123
K946299 · Skylark Device Co., Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 181d
Cleared Jun 22, 1995
MEDI-TRAC EEG ELECTRODE
K950782 · Graphic Controls Corp.
GXY · Electrode, Cutaneous · 121d
Cleared Jun 02, 1995
DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
K950956 · Bio-Vascular, Inc.
GXQ · Dura Substitute · 92d
Cleared May 22, 1995
NIHON KOHDEN ELECTROENCEPHALOGRAPH
K944678 · Nihon Kohden America, Inc.
GWQ · Full-montage Standard Electroencephalograph · 242d
Cleared May 18, 1995
75K STAIGHT DRILL
K943541 · Stryker Corp.
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 300d
Cleared May 18, 1995
RIB RESECTOR
K951492 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 48d
Cleared May 10, 1995
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
K950208 · Nihon Kohden America, Inc.
GWF · Stimulator, Electrical, Evoked Response · 112d
Cleared May 03, 1995
ISOTRON III
K941815 · Excel Tech. , Ltd.
LIH · Interferential Current Therapy · 386d
Cleared Apr 24, 1995
MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE
K946318 · Physiometrix, Inc.
GXY · Electrode, Cutaneous · 117d

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All categories 4754 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 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