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
Dec 20, 2013
V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
172d
Cleared
Dec 20, 2013
WANDY SELF-ADHESIVE ELECTRODES
GXY
Electrode, Cutaneous
87d
Cleared
Dec 19, 2013
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
HCG
Device, Neurovascular Embolization
91d
Not Cleared
Dec 18, 2013
RESTLESS LEG DEVICE
OTX
Foot Wrap For Treating Restless Leg Syndrome Symptoms
1056d
Not Cleared
Dec 18, 2013
SYMPHONY DEVICE
OVP
Vibratory Counter-stimulation
889d
Cleared
Dec 17, 2013
PRIMADO2 TOTAL SURGICAL SYSTEM
HBC
Motor, Drill, Electric
148d
Cleared
Dec 16, 2013
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
GXQ
Dura Substitute
181d
Cleared
Dec 13, 2013
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
JXG
Shunt, Central Nervous System And Components
597d
Not Cleared
Dec 13, 2013
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
283d
Cleared
Dec 10, 2013
CANARY BREATHING SYSTEM
HCC
Device, Biofeedback
193d
Cleared
Dec 06, 2013
OSTEOMED NEURO RONGEUR
HAE
Rongeur, Manual
168d
Cleared
Nov 27, 2013
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
GWQ
Full-montage Standard Electroencephalograph
197d
Cleared
Nov 22, 2013
ADHESIVE ELECTRODES
GXY
Electrode, Cutaneous
95d
Cleared
Nov 21, 2013
PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
120d
Cleared
Nov 15, 2013
ELECTRONIC PULSE STIMULATOR
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
142d
Cleared
Nov 12, 2013
I RUNE (I-200L)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
461d
Cleared
Oct 28, 2013
JIAJIAN POINTOSELECT DIGITAL
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
311d
Cleared
Oct 25, 2013
RAUMEDIC-PTO-MONITORING-SYSTEM
GWM
Device, Monitoring, Intracranial Pressure
238d
Cleared
Oct 18, 2013
CRANIAL MAP NEURO
HAW
Neurological Stereotaxic Instrument
172d
Cleared
Oct 17, 2013
UNIVERSAL NEURO 3 SYSTEM
GWO
Plate, Cranioplasty, Preformed, Alterable
122d
Cleared
Oct 10, 2013
BARRICADE EMBOLIZATION COIL SYSTEM
HCG
Device, Neurovascular Embolization
63d
Cleared
Oct 08, 2013
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
GXQ
Dura Substitute
180d
Cleared
Oct 04, 2013
MICROPLEX COIL SYSTEM (MCS)
HCG
Device, Neurovascular Embolization
99d
Cleared
Oct 01, 2013
TRINITY ELE
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
153d
Cleared
Sep 30, 2013
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
GXR
Cover, Burr Hole
90d
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