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
4723 Neurology devices
Cleared
Mar 02, 2012
SOLITAIRE FR REVASCULARIZATION DEVICE
NRY
Catheter, Thrombus Retriever
102d
Cleared
Mar 02, 2012
DELTAMAXX 18 MICROCOIL SYSTEM
HCG
Device, Neurovascular Embolization
32d
Cleared
Mar 01, 2012
FD TENS 2070
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
262d
Cleared
Mar 01, 2012
PAIN-AID
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
141d
Cleared
Feb 27, 2012
BARF BAND
MVV
Device, Acupressure
340d
Cleared
Feb 22, 2012
LEFORTE NEURO SYSTEM BONE PLATE
GWO
Plate, Cranioplasty, Preformed, Alterable
148d
Cleared
Feb 17, 2012
GEODESIC EEG MOBILE 100 (GEM 100)
GWQ
Full-montage Standard Electroencephalograph
185d
Cleared
Feb 16, 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
JXG
Shunt, Central Nervous System And Components
78d
Cleared
Feb 15, 2012
ELECTROPULSE-COSMETIC
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
58d
Cleared
Feb 02, 2012
CMAP PRO
IKN
Electromyograph, Diagnostic
108d
Cleared
Jan 27, 2012
ELECTRO-CAP SYSTEM
GXY
Electrode, Cutaneous
169d
Cleared
Jan 27, 2012
SPOTLIGHT ACCESS SYSTEM
GZT
Retractor, Self-retaining, For Neurosurgery
81d
Cleared
Jan 25, 2012
THERATRODE
GXY
Electrode, Cutaneous
167d
Cleared
Jan 20, 2012
NEUROTECH RECOVERY
GXY
Electrode, Cutaneous
109d
Cleared
Jan 09, 2012
NEUROTECH PLUS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
157d
Cleared
Jan 09, 2012
SYNTHECEL DURA REPLACEMENT DEVICES
GXQ
Dura Substitute
84d
Cleared
Jan 05, 2012
ELECTRO-GEL
GYB
Media, Electroconductive
199d
Cleared
Jan 05, 2012
STRYKER UNIVERSAL NEURO 3 SYSTEM
GWO
Plate, Cranioplasty, Preformed, Alterable
125d
Cleared
Dec 21, 2011
GALAXY SYSTEM
OLV
Standard Polysomnograph With Electroencephalograph
250d
Cleared
Dec 16, 2011
SBV2, MULTICHARGER MODEL MC10V2
LEL
Device, Sleep Assessment
198d
Cleared
Dec 16, 2011
SPOTLIGHT ACCESS SYSTEM
GZT
Retractor, Self-retaining, For Neurosurgery
74d
Cleared
Dec 16, 2011
HYDROCOIL EMBOLIC SYSTEM (HES)
HCG
Device, Neurovascular Embolization
24d
Cleared
Dec 16, 2011
ANSPACH DISSECTION TOOLS
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
24d
Cleared
Dec 13, 2011
TARGET DETACHABLE COIL
HCG
Device, Neurovascular Embolization
25d
Not Cleared
Dec 13, 2011
INFRASCANNER, MODEL 1000
OPT
Infrared Hematoma Detector
614d
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