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
6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
Cleared
Jul 20, 2012
GEMORE TENS SYSTEM
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
144d
Cleared
Jul 20, 2012
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
GWM
Device, Monitoring, Intracranial Pressure
95d
Cleared
Jul 17, 2012
MERIDIAN CRANIAL PERFORATOR
HBF
Drills, Burrs, Trephines & Accessories (compound, Powered)
83d
Cleared
Jul 12, 2012
PRESSON ELECTRODE
GXZ
Electrode, Needle
72d
Cleared
Jun 29, 2012
ICTA
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
154d
Cleared
Jun 22, 2012
EMG RECORDING ELECTRODE ASSEMBLY
IKT
Electrode, Needle, Diagnostic Electromyograph
140d
Cleared
Jun 22, 2012
CRYO-TOUCH III
GXH
Device, Surgical, Cryogenic
133d
Cleared
Jun 20, 2012
X4
OMC
Reduced- Montage Standard Electroencephalograph
127d
Cleared
Jun 19, 2012
MICROEEG SYSTEM
GWQ
Full-montage Standard Electroencephalograph
265d
Cleared
Jun 15, 2012
DURAGEN SECURE DURAL REGNERATION MATRIX
GXQ
Dura Substitute
108d
Cleared
Jun 12, 2012
STERILE DISPOSABLES FOR MER
GZL
Electrode, Depth
152d
Cleared
Jun 11, 2012
STRYKER QUIKFLAP STERILE PROCEDURE PACK
GWO
Plate, Cranioplasty, Preformed, Alterable
126d
Cleared
Jun 11, 2012
DISPOSABLE ADHESIVE SURFACE ELECTRODE
GXY
Electrode, Cutaneous
115d
Cleared
Jun 06, 2012
ADHERENT VISUAL STIMULATOR GOGGLES
GWE
Stimulator, Photic, Evoked Response
166d
Cleared
Jun 05, 2012
ULTIMA NEO
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
151d
Cleared
Jun 05, 2012
BRAIN PORT
GZT
Retractor, Self-retaining, For Neurosurgery
90d
Cleared
May 24, 2012
PRAEZIS PLUS
HAW
Neurological Stereotaxic Instrument
444d
Cleared
May 24, 2012
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
JXG
Shunt, Central Nervous System And Components
90d
Cleared
May 24, 2012
MAYFIELD SKULL CLAMP
HBL
Holder, Head, Neurosurgical (skull Clamp)
84d
Cleared
May 22, 2012
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
GWF
Stimulator, Electrical, Evoked Response
235d
Cleared
May 21, 2012
VISIONSEARCH 1
GWE
Stimulator, Photic, Evoked Response
129d
Cleared
May 17, 2012
LONG LIFE PADTM
GXY
Electrode, Cutaneous
86d
Cleared
May 02, 2012
JIAJIAN TENS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
267d
Cleared
May 02, 2012
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
GWM
Device, Monitoring, Intracranial Pressure
196d
Cleared
Apr 25, 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
HCG
Device, Neurovascular Embolization
30d
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