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
4401–4425 of 4767
Cleared Jul 01, 1986
ELEFIX ELECTRODE CREAM
K860210 · Nihon Kohden America, Inc.
GYB · Media, Electroconductive · 160d
Cleared Jul 01, 1986
FUJITSU MALLEABLE - TIP BRAIN SPATULA
K862331 · Downs Surgical , Ltd.
HAO · Instrument, Surgical, Non-powered · 12d
Cleared Jun 26, 1986
JELTRODE
K861956 · Henley Intl.
GXY · Electrode, Cutaneous · 37d
Cleared Jun 19, 1986
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
K861377 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 66d
Cleared Jun 05, 1986
4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH
K854665 · Nihon Kohden America, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 197d
Cleared May 09, 1986
MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT
K855107 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 137d
Cleared May 09, 1986
NEUROSURGICAL INSTURMENTS (VARIOUS)
K861630 · Downs Surgical , Ltd.
HAO · Instrument, Surgical, Non-powered · 10d
Cleared Apr 30, 1986
PAINBLOCKER WA5000
K854334 · Wallach Surgical Devices, Inc.
GXH · Device, Surgical, Cryogenic · 184d
Cleared Apr 30, 1986
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457 · Oxford Medilog, Inc.
GWN · Nystagmograph · 84d
Cleared Apr 22, 1986
MODIFIED BRAIN ATLAS III
K854362 · Bio-Logic Systems Corp.
GWE · Stimulator, Photic, Evoked Response · 175d
Cleared Mar 27, 1986
DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER
K854268 · Del Mar Avionics
GWQ · Full-montage Standard Electroencephalograph · 155d
Cleared Feb 28, 1986
SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM
K853178 · Oxford Medilog, Inc.
HCB · Device, Aversive Conditioning · 213d
Cleared Feb 28, 1986
FASTENS(TM)
K854316 · Medical Devices, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 123d
Cleared Feb 21, 1986
VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
K853992 · Valley Forge Scientific Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 147d
Cleared Feb 20, 1986
INTRACRANIAL PRESSURE MONITORING KIT 070
K853864 · Camino Laboratories, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 156d
Cleared Feb 14, 1986
MINIPAC PERSONAL TOUCH (TM)
K854761 · Medical Devices, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 79d
Cleared Feb 13, 1986
MEDILAS 2
K853580 · Endo Lase, Inc.
LKW · Laser, Neurosurgical · 171d
Cleared Feb 07, 1986
5.0 IOP & 7.5 IOP PROBES
K853432 · Diasonics, Inc.
GXW · Echoencephalograph · 176d
Cleared Jan 21, 1986
MINIPAC (TM)
K854317 · Medical Devices, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 85d
Cleared Jan 10, 1986
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
K855058 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 23d
Cleared Dec 27, 1985
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · Cordis Corp.
GWM · Device, Monitoring, Intracranial Pressure · 37d
Cleared Dec 12, 1985
L.E.D. GOGGLES, MODEL 580-LEDGOG
K852533 · Bio-Logic Systems Corp.
GWE · Stimulator, Photic, Evoked Response · 181d
Cleared Dec 06, 1985
EMPI, NMS/SUE CUTANEOUS ELECTRODE
K854513 · Empi
GXY · Electrode, Cutaneous · 24d
Cleared Nov 27, 1985
NYSTAGMOGRAPH EOG/ENG ANALYSES
K851190 · Nicolet Biomedical Instruments
GWN · Nystagmograph · 246d
Cleared Nov 27, 1985
HEYER-SCHULTE SYRINGO PERITONEAL SHUNT
K854049 · American V. Mueller
JXG · Shunt, Central Nervous System And Components · 55d

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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