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
4750 Neurology devices
Cleared
Jun 23, 1999
ACTIWATCH-SCORE
GWQ
Full-montage Standard Electroencephalograph
86d
Cleared
Jun 22, 1999
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
IKT
Electrode, Needle, Diagnostic Electromyograph
305d
Cleared
Jun 22, 1999
BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150
GXY
Electrode, Cutaneous
75d
Cleared
Jun 18, 1999
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO
GXY
Electrode, Cutaneous
368d
Cleared
Jun 09, 1999
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
GZL
Electrode, Depth
70d
Cleared
Jun 07, 1999
MEDIPOINT
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
287d
Cleared
Jun 04, 1999
SUGITA TITANIUM ANEURYSM CLIP
HCH
Clip, Aneurysm
134d
Cleared
Jun 03, 1999
XK-95 HIGH SPEED MOTOR DRILL SYSTEM
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
203d
Cleared
Jun 03, 1999
LAMITRODE LEADS
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
107d
Cleared
Jun 03, 1999
INSIGHT MILLENNIUM
HCC
Device, Biofeedback
86d
Cleared
Jun 03, 1999
KSEA NEURO-FIBERSCOPE
GWG
Endoscope, Neurological
64d
Cleared
May 27, 1999
ELECTRODE NEEDLES
IKT
Electrode, Needle, Diagnostic Electromyograph
143d
Cleared
May 26, 1999
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
JXG
Shunt, Central Nervous System And Components
415d
Cleared
May 19, 1999
VECTORVISION2
HAW
Neurological Stereotaxic Instrument
201d
Cleared
May 19, 1999
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
OLV
Standard Polysomnograph With Electroencephalograph
90d
Cleared
May 19, 1999
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
HCC
Device, Biofeedback
89d
Cleared
May 19, 1999
DIAMOND II VALVE
JXG
Shunt, Central Nervous System And Components
23d
Cleared
May 17, 1999
SYNERGY IOM SYSTEM
IKN
Electromyograph, Diagnostic
185d
Cleared
Apr 29, 1999
THE BAGNOLI-8 EMG SYSTEM
HCC
Device, Biofeedback
83d
Cleared
Apr 29, 1999
OPTICAL TRACKING SYSTEM (OTS)
HAW
Neurological Stereotaxic Instrument
62d
Cleared
Apr 28, 1999
MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015
GWG
Endoscope, Neurological
84d
Cleared
Apr 23, 1999
RAPIDFLAP CRANIAL CLAMP
GXN
Plate, Cranioplasty, Preformed, Non-alterable
25d
Cleared
Apr 22, 1999
FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
HAW
Neurological Stereotaxic Instrument
90d
Cleared
Apr 20, 1999
EEG ELECTRODES MODEL 445 SERIES
GXY
Electrode, Cutaneous
313d
Cleared
Apr 19, 1999
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
JXG
Shunt, Central Nervous System And Components
405d
Looking for a specific neurology device? Search by device name, K-number or manufacturer.
Search all Neurology 510(k) devices