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
4715 Neurology devices
Cleared
Oct 30, 2015
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
OMC
Reduced- Montage Standard Electroencephalograph
100d
Cleared
Oct 30, 2015
DURAFORM Dural Graft Implant
GXQ
Dura Substitute
60d
Cleared
Oct 27, 2015
Codman Certas Plus Programmable Valve
JXG
Shunt, Central Nervous System And Components
85d
Cleared
Oct 23, 2015
ICS CHARTR EP 200 WITH VEMP
GWJ
Stimulator, Auditory, Evoked Response
303d
Cleared
Oct 23, 2015
R-40 EEG Amplifier
GWL
Amplifier, Physiological Signal
133d
Cleared
Oct 21, 2015
ClearPoint System
HAW
Neurological Stereotaxic Instrument
411d
Cleared
Oct 20, 2015
Palm TENS
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
253d
Cleared
Oct 19, 2015
QBioScan
GZO
Device, Galvanic Skin Response Measurement
207d
Cleared
Oct 16, 2015
EV-820 OTC Pain Relief TENS
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
136d
Cleared
Oct 09, 2015
Dr-Ho's Foot Pad Electrode
GXY
Electrode, Cutaneous
108d
Cleared
Sep 29, 2015
Neon EEG
GXY
Electrode, Cutaneous
110d
Cleared
Sep 25, 2015
BiowaveHOME Neuromodulation Pain Therapy Device
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
29d
Cleared
Sep 24, 2015
SudoC
GZO
Device, Galvanic Skin Response Measurement
48d
Cleared
Sep 18, 2015
STARband, STARlight
OAN
Orthosis, Cranial, Laser Scan
63d
Cleared
Sep 09, 2015
NFANT Feeding Solution
HCC
Device, Biofeedback
273d
Cleared
Sep 02, 2015
DirectInject
GXP
Methyl Methacrylate For Cranioplasty
253d
Cleared
Aug 28, 2015
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
IKT
Electrode, Needle, Diagnostic Electromyograph
270d
Cleared
Aug 28, 2015
ANAM Test System: Military Battery
PKQ
Computerized Cognitive Assessment Aid
217d
Cleared
Aug 27, 2015
RxG Distraction System
PBJ
Cranial Distraction System
156d
Cleared
Aug 26, 2015
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
GWO
Plate, Cranioplasty, Preformed, Alterable
30d
Cleared
Aug 25, 2015
Zekang Self-adhesive Electrode
GXY
Electrode, Cutaneous
134d
Cleared
Aug 21, 2015
Lifelines iEEG
OLT
Non-normalizing Quantitative Electroencephalograph Software
256d
Cleared
Aug 19, 2015
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
GWF
Stimulator, Electrical, Evoked Response
201d
Cleared
Aug 14, 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
217d
Cleared
Aug 13, 2015
Mitsar-EEG
GWQ
Full-montage Standard Electroencephalograph
276d
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