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
Jun 14, 2019
ELECTRODES PAD
GXY
Electrode, Cutaneous
88d
Cleared
Jun 13, 2019
XenoSure Dura Biologic Patch
GXQ
Dura Substitute
177d
Cleared
Jun 12, 2019
Avid IF2
LIH
Interferential Current Therapy
163d
Cleared
Jun 07, 2019
Masimo O3 Regional Oximeter System
MUD
Oximeter, Tissue Saturation
274d
Not Cleared
Jun 07, 2019
IB-Stim
QHH
Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)
225d
Cleared
Jun 03, 2019
ReWalk Restore
PHL
Powered Exoskeleton
109d
Cleared
May 31, 2019
NeuroShield
JXI
Cuff, Nerve
114d
Cleared
May 24, 2019
COMPLETE CONTROL System Gen2
GXY
Electrode, Cutaneous
30d
Cleared
May 21, 2019
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
GWO
Plate, Cranioplasty, Preformed, Alterable
236d
Not Cleared
May 20, 2019
Nerivio Migra
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
195d
Cleared
May 15, 2019
SOFIA EX Intracranial Support Catheter
DQY
Catheter, Percutaneous
236d
Cleared
May 12, 2019
MR8 Drill System, Midas Rex MR8 ClearView Tools
HBC
Motor, Drill, Electric
145d
Cleared
May 11, 2019
SPEAC System
POS
Physiological Signal Based Seizure Monitoring System
271d
Cleared
May 09, 2019
ATEC IOM Accessory Instruments
PDQ
Neurosurgical Nerve Locator
227d
Cleared
May 03, 2019
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
GXI
Probe, Radiofrequency Lesion
63d
Cleared
May 01, 2019
Synchro2 Support Guidewire
MOF
Guide, Wire, Catheter, Neurovasculature
30d
Cleared
Apr 30, 2019
Eclipse 2L
MJN
Catheter, Intravascular Occluding, Temporary
179d
Cleared
Apr 26, 2019
Portable Electro-Stimulation Therapy Device
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
266d
Cleared
Apr 26, 2019
Penumbra System 3D Revascularization Device
NRY
Catheter, Thrombus Retriever
59d
Cleared
Apr 24, 2019
AXS Vecta Aspiration System
NRY
Catheter, Thrombus Retriever
79d
Not Cleared
Apr 24, 2019
Comaneci, Comaneci Petit, Comaneci 17
PUU
Temporary Coil Embolization Assist Device
573d
Not Cleared
Apr 19, 2019
Monarch eTNS System
QGL
Transcutaneous Nerve Stimulator For Adhd
263d
Cleared
Apr 17, 2019
0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter
NRY
Catheter, Thrombus Retriever
166d
Cleared
Apr 12, 2019
D-Clip
HCH
Clip, Aneurysm
386d
Cleared
Apr 11, 2019
Codman Electrosurgical Generator, Foot Pedal
GEI
Electrosurgical, Cutting & Coagulation & Accessories
113d
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