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
4276–4300 of 4767
Cleared Jun 17, 1988
ORTHOPAEDIC AND SPINAL RING CURRETTES
K882072 · Karlin Technology, Inc.
JXH · Methyl Methacrylate For Aneurysmorrhaphy · 31d
Cleared Jun 16, 1988
SPARE MS 700 TENS ELECTRODE
K881871 · Lectec Corp.
GXY · Electrode, Cutaneous · 44d
Cleared Jun 16, 1988
TENS ELECTRODE MODEL 238P
K881872 · Lectec Corp.
GXY · Electrode, Cutaneous · 44d
Cleared Jun 10, 1988
CRANK FRAME RETRACTOR
K882071 · Karlin Technology, Inc.
GZT · Retractor, Self-retaining, For Neurosurgery · 24d
Cleared Jun 06, 1988
NEW SIZES SUGITA CLIPS
K881911 · Downs Surgical , Ltd.
HCI · Applier, Aneurysm Clip · 28d
Cleared Jun 06, 1988
SANO CLIP APPLIERS & REMOVERS
K881912 · Downs Surgical , Ltd.
HCI · Applier, Aneurysm Clip · 28d
Cleared May 31, 1988
RANEY CLIPS
K881265 · Zimmer, Inc.
HBO · Clip, Scalp · 68d
Cleared May 25, 1988
MODEL 3487A PISCES EPIDURAL LEAD
K881491 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 47d
Cleared May 04, 1988
CADWELL EXCEL
K880088 · Cadwell Laboratories, Inc.
GWF · Stimulator, Electrical, Evoked Response · 113d
Cleared May 04, 1988
VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
K881183 · Camino Laboratories, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 44d
Cleared Apr 21, 1988
KIN-COM JR
K881388 · Chattanooga Group, Inc.
LBB · Dynamometer, Ac-powered · 17d
Cleared Apr 15, 1988
EMPI MODEL 989, TENS
K881114 · Empi
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 31d
Cleared Apr 13, 1988
ENDOMED 433
K870384 · Henley Intl.
LIH · Interferential Current Therapy · 439d
Cleared Apr 13, 1988
DISPOSABLE WET FIELD ERASER
K880925 · Advanced Surgical Products, Inc.
GXI · Probe, Radiofrequency Lesion · 40d
Cleared Apr 13, 1988
DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150
K880951 · Advanced Surgical Products, Inc.
GXI · Probe, Radiofrequency Lesion · 37d
Cleared Apr 06, 1988
TECA/MEDELEC MISTRAL
K880593 · Teca, Inc.
GWE · Stimulator, Photic, Evoked Response · 55d
Cleared Apr 06, 1988
CRANK FRAME RETRACTOR
K881160 · T. Korossurgical Instruments Corp.
GZT · Retractor, Self-retaining, For Neurosurgery · 19d
Cleared Mar 25, 1988
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
K874136 · Bio-Logic Systems Corp.
GWE · Stimulator, Photic, Evoked Response · 164d
Cleared Mar 22, 1988
MODIFIED NICOLET VIKING SYSTEM
K880573 · Nicolet Biomedical Instruments
IKN · Electromyograph, Diagnostic · 41d
Cleared Mar 17, 1988
THE STORZ BIPOLAR PENCIL AND CORD
K880293 · Storz Instrument Co.
GXI · Probe, Radiofrequency Lesion · 52d
Cleared Mar 11, 1988
MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
K880172 · Cooper Lasersonics, Inc.
LKW · Laser, Neurosurgical · 56d
Cleared Mar 04, 1988
TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING
K880649 · Labeltape Meditect, Inc.
GXY · Electrode, Cutaneous · 16d
Cleared Mar 02, 1988
CODMAN SURGICAL PATTIE
K880402 · Codman & Shurtleff, Inc.
HBA · Neurosurgical Paddie · 33d
Cleared Feb 12, 1988
TARGET PROGRAM & EPSON HX-20 COMPUTER
K872877 · Walter Lorenz Surgical, Inc.
HAW · Neurological Stereotaxic Instrument · 206d
Cleared Feb 11, 1988
MALLEABLE PTFE COATED BRAIN SPATULAE
K880278 · Downs Surgical , Ltd.
HAO · Instrument, Surgical, Non-powered · 20d

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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