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
4759 Neurology devices
Cleared
Mar 05, 1993
INTELECT IFC2
LIH
Interferential Current Therapy
170d
Cleared
Mar 02, 1993
PHASIS ELECTROMYOGRAPH
IKN
Electromyograph, Diagnostic
279d
Cleared
Feb 19, 1993
DISPOSABLE NEUROVIEW ENDOSCOPE
GWG
Endoscope, Neurological
219d
Cleared
Feb 19, 1993
DISPOSABLE BIOPSY FORCEP
GWG
Endoscope, Neurological
92d
Cleared
Feb 12, 1993
MAYFIELD ADULT DISPOSABLE SKULL PIN
HBL
Holder, Head, Neurosurgical (skull Clamp)
199d
Cleared
Feb 12, 1993
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
IKT
Electrode, Needle, Diagnostic Electromyograph
157d
Cleared
Feb 10, 1993
REUSABLE FINGER CLIP RECORDING ELECTRODE
GXY
Electrode, Cutaneous
90d
Cleared
Feb 04, 1993
THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR
GWQ
Full-montage Standard Electroencephalograph
188d
Cleared
Jan 26, 1993
THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH
GWQ
Full-montage Standard Electroencephalograph
174d
Cleared
Jan 22, 1993
SD-602 SD MODE 11, SD-603 SD MOD 111
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
70d
Cleared
Jan 14, 1993
DYNATRON 400
LIH
Interferential Current Therapy
154d
Cleared
Dec 30, 1992
NEUROLOGICAL SPONGE
HBA
Neurosurgical Paddie
446d
Cleared
Dec 21, 1992
CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS
GWG
Endoscope, Neurological
153d
Cleared
Dec 10, 1992
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
JXG
Shunt, Central Nervous System And Components
90d
Cleared
Dec 09, 1992
TUM-E-VAC BITE BLOCK
JXL
Block, Bite
226d
Cleared
Dec 08, 1992
DISPOSABLE MONOPLAR MEDDLE ELECTRODES
GXE
Leukotome
354d
Cleared
Dec 03, 1992
SPECTRAL EEG MONITOR MODEL A1000
OLT
Non-normalizing Quantitative Electroencephalograph Software
162d
Cleared
Dec 01, 1992
MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE
GXD
Generator, Lesion, Radiofrequency
211d
Cleared
Nov 23, 1992
AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
HAW
Neurological Stereotaxic Instrument
88d
Cleared
Nov 05, 1992
MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
111d
Cleared
Oct 30, 1992
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
JXG
Shunt, Central Nervous System And Components
189d
Cleared
Oct 26, 1992
SENSORMEDICS 4000 SERIES SLEEP SYSTEM
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
304d
Cleared
Oct 23, 1992
AD-TECH SUB DURAL ELECTRODEDS
GYC
Electrode, Cortical
86d
Cleared
Oct 23, 1992
TX-3 SD
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
79d
Cleared
Oct 15, 1992
SD-605 SD II PROGRAM
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
71d
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