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
4706 Neurology devices
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
Cleared
Apr 10, 2019
NAV PAK Needle, NIM NAV PAK Needle
PDQ
Neurosurgical Nerve Locator
197d
Cleared
Apr 04, 2019
Dome Electrode
GXY
Electrode, Cutaneous
42d
Cleared
Apr 03, 2019
DAEHAN Disposable CUP Electrodes
GXY
Electrode, Cutaneous
429d
Cleared
Apr 03, 2019
HORIZON TMS Therapy System with Navigation
OBP
Transcranial Magnetic Stimulator
118d
Cleared
Mar 29, 2019
Freedom Spinal Cord Stimulator (SCS) System
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
182d
Cleared
Mar 29, 2019
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
98d
Not Cleared
Mar 28, 2019
Leica FL400
QFX
Diagnostic Neurosurgical Microscope Filter
335d
Cleared
Mar 26, 2019
SM Electrodes
GXY
Electrode, Cutaneous
132d
Cleared
Mar 22, 2019
Nexstim Navigated Brain Therapy (NBT) System 2
OBP
Transcranial Magnetic Stimulator
176d
Cleared
Mar 22, 2019
Nalu Neurostimulation System
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
140d
Cleared
Mar 22, 2019
Aristotle 18 Guidewire, 200cm, Soft Profile
MOF
Guide, Wire, Catheter, Neurovasculature
86d
Cleared
Mar 21, 2019
Ballast 088 Long Sheath
DQY
Catheter, Percutaneous
153d
Cleared
Mar 21, 2019
Route 92 Medical Delivery Catheter
DQY
Catheter, Percutaneous
27d
Cleared
Mar 19, 2019
AE-120A EEG Head Set
OMC
Reduced- Montage Standard Electroencephalograph
90d
Cleared
Mar 15, 2019
HORIZON TMS Therapy System
OBP
Transcranial Magnetic Stimulator
156d
Cleared
Mar 15, 2019
HIVOX OTC Electrical Stimulator
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
29d
Cleared
Mar 14, 2019
JKH Stimulator Plus
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
211d
Cleared
Mar 14, 2019
L300 Go System
GZI
Stimulator, Neuromuscular, External Functional
31d
Looking for a specific neurology device? Search by device name, K-number or manufacturer.
Search all Neurology 510(k) devices