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
Jan 13, 2016
NuVasiveNVM5 System
PDQ
Neurosurgical Nerve Locator
100d
Cleared
Jan 05, 2016
Quell
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Dec 29, 2015
VisualEyes
GWN
Nystagmograph
153d
Cleared
Dec 29, 2015
Traxcess Pro 14 Guidewire
MOF
Guide, Wire, Catheter, Neurovasculature
70d
Cleared
Dec 23, 2015
2-in-1 Abdominal Muscle Training & Back Pain Relief System
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
145d
Cleared
Dec 23, 2015
Solitaire Platinum Revascularization Device
NRY
Catheter, Thrombus Retriever
62d
Cleared
Dec 22, 2015
Pacifier Activated Lullaby (PAL®)
HCC
Device, Biofeedback
246d
Cleared
Dec 22, 2015
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
84d
Cleared
Dec 18, 2015
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
JXG
Shunt, Central Nervous System And Components
260d
Cleared
Dec 18, 2015
ROSA Brain
HAW
Neurological Stereotaxic Instrument
212d
Cleared
Dec 16, 2015
Counter OTC TENS Device, Model CSD-737Z
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
216d
Cleared
Dec 02, 2015
Reaxon Plus
JXI
Cuff, Nerve
338d
Cleared
Nov 25, 2015
SonicLift
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
315d
Cleared
Nov 23, 2015
QuadraSphere Microspheres
KRD
Device, Vascular, For Promoting Embolization
28d
Cleared
Nov 21, 2015
PainKARE
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
218d
Cleared
Nov 20, 2015
Collagen Dural Regeneration Matrix
GXQ
Dura Substitute
238d
Cleared
Nov 20, 2015
BioArchitects Patient Specific Cranial/Craniofacial Plate
GXN
Plate, Cranioplasty, Preformed, Non-alterable
150d
Cleared
Nov 16, 2015
ICS Impulse
GWN
Nystagmograph
165d
Cleared
Nov 16, 2015
Viradius Neurowire
MOF
Guide, Wire, Catheter, Neurovasculature
133d
Cleared
Nov 12, 2015
Entropy Module, E-ENTROPY-01
OLW
Index-generating Electroencephalograph Software
279d
Cleared
Nov 09, 2015
Patient Contoured Implant-PEEK (PCI-PEEK)
GXN
Plate, Cranioplasty, Preformed, Non-alterable
171d
Cleared
Nov 05, 2015
Tyece OTC TENS Device
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
260d
Cleared
Nov 05, 2015
IdentEvent
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
233d
Cleared
Oct 30, 2015
SYMBIS Surgical System
HAW
Neurological Stereotaxic Instrument
336d
Cleared
Oct 30, 2015
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
NCX
System, Hypothermia, Intravenous, Cooling
291d
Looking for a specific neurology device? Search by device name, K-number or manufacturer.
Search all Neurology 510(k) devices