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
3851–3875 of 4754
Cleared Jan 22, 1996
ACUPLUS
K954334 · S.H.P. Intl. Pty., Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 126d
Cleared Jan 17, 1996
DG PORTABLE SYSTEM
K954157 · Medelec , Ltd.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 134d
Cleared Jan 16, 1996
A-1050 EEG MONITOR
K952347 · Aspect Medical Systems, Inc.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 242d
Cleared Jan 03, 1996
DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123
K944314 · Bio-Logic Systems Corp.
GXY · Electrode, Cutaneous · 492d
Cleared Dec 19, 1995
RIGID NEUROVIEW ENDOSCOPE
K954899 · Neuro Navigational Corp.
GWG · Endoscope, Neurological · 55d
Cleared Dec 06, 1995
MAYFIELD CHILD DISPOSABLE SKULL PIN
K941558 · Ohio Medical Instrument Co., Inc.
HBL · Holder, Head, Neurosurgical (skull Clamp) · 615d
Cleared Dec 06, 1995
EMG DISC RECORDING ELECTRODE WITH PIN
K952690 · Chalgren Enterprises, Inc.
GXY · Electrode, Cutaneous · 177d
Cleared Dec 06, 1995
EMG DISC RECORDING ELECTRODE WITH PIN
K952908 · Chalgren Enterprises, Inc.
GXY · Electrode, Cutaneous · 166d
Cleared Dec 06, 1995
BRAY RONGEUR
K954699 · Johnson & Johnson Professionals, Inc.
HAE · Rongeur, Manual · 55d
Cleared Nov 27, 1995
MODEL NOS. 7495 AND 501826 EXTENSIONS
K954886 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 151d
Cleared Nov 15, 1995
NEUROLOGICAL DIAGNOSTIC DEVICES
K943449 · Henley Intl.
GXY · Electrode, Cutaneous · 485d
Cleared Nov 07, 1995
EXCEL EMG
K941144 · Excel Tech. , Ltd.
IKN · Electromyograph, Diagnostic · 607d
Cleared Nov 01, 1995
PRECLUDE DURA SUBSTITUTE
K953969 · W.L. Gore & Associates, Inc.
GXQ · Dura Substitute · 71d
Cleared Oct 31, 1995
RE-USABLE MONOPOLAR NEEDLE
K953886 · Chalgren Enterprises, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 75d
Cleared Oct 31, 1995
RE-USABLE CONCENTRIC NEEDLE
K953887 · Chalgren Enterprises, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 75d
Cleared Oct 26, 1995
COMAN(R) CU-11 MODEL NUMBER 82-6634
K945585 · Johnson & Johnson Professionals, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 346d
Cleared Oct 24, 1995
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
K954021 · Johnson & Johnson Professionals, Inc.
JXG · Shunt, Central Nervous System And Components · 85d
Cleared Oct 19, 1995
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
K944595 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 395d
Cleared Oct 13, 1995
PAIN DOC
K941342 · Regulatory & Marketing Services, Inc.
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 598d
Cleared Oct 12, 1995
MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS
K953449 · Physiometrix, Inc.
GWQ · Full-montage Standard Electroencephalograph · 86d
Cleared Oct 12, 1995
INSTRUMENT SCOPE
K953685 · Clarus Medical Systems, Inc.
GWG · Endoscope, Neurological · 66d
Cleared Oct 06, 1995
22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN
K953219 · Chalgren Enterprises, Inc.
GXY · Electrode, Cutaneous · 88d
Cleared Oct 06, 1995
32MM NICKEL PLATED DISC ELECTRODE
K953220 · Chalgren Enterprises, Inc.
GXY · Electrode, Cutaneous · 88d
Cleared Oct 03, 1995
NONPOWERED NEUROSURGICAL INSTRUMENT
K953173 · United States Surgical, A Division of Tyco Healthc
GWG · Endoscope, Neurological · 88d
Cleared Sep 29, 1995
MULLAN GANGLION MICROCOMPRESSION SET
K940973 · Cook, Inc.
HAO · Instrument, Surgical, Non-powered · 575d

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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