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
Jul 16, 2013
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
GWG
Endoscope, Neurological
60d
Not Cleared
Jul 15, 2013
NEBA SYSTEM
NCG
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
585d
Cleared
Jul 12, 2013
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
PDQ
Neurosurgical Nerve Locator
109d
Cleared
Jul 02, 2013
SENSUS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
90d
Cleared
Jun 28, 2013
SUDO PATH
GZO
Device, Galvanic Skin Response Measurement
29d
Cleared
Jun 27, 2013
EARPROBE
GWJ
Stimulator, Auditory, Evoked Response
65d
Cleared
Jun 21, 2013
INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
GXY
Electrode, Cutaneous
88d
Cleared
Jun 20, 2013
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
HBA
Neurosurgical Paddie
652d
Cleared
Jun 18, 2013
MULTI LEAD TRIAL CABLE
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
109d
Cleared
Jun 17, 2013
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
GXR
Cover, Burr Hole
130d
Cleared
Jun 10, 2013
STARBAND
OAN
Orthosis, Cranial, Laser Scan
164d
Cleared
Jun 05, 2013
NEUROEPG SYSTEM
GWF
Stimulator, Electrical, Evoked Response
174d
Cleared
Jun 04, 2013
LYOPLANT ONLAY
GXQ
Dura Substitute
265d
Cleared
Jun 03, 2013
OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
PBJ
Cranial Distraction System
167d
Cleared
May 30, 2013
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
GXY
Electrode, Cutaneous
114d
Cleared
May 08, 2013
OLYMPIC BRAINZ MONITOR
OMA
Amplitude-integrated Electroencephalograph
219d
Cleared
May 07, 2013
DILATOR TUBE SET
PDQ
Neurosurgical Nerve Locator
434d
Cleared
May 02, 2013
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
GWQ
Full-montage Standard Electroencephalograph
282d
Cleared
May 02, 2013
SYNERGY FOCUS DESKTOP VERSION
GWF
Stimulator, Electrical, Evoked Response
80d
Cleared
May 01, 2013
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE
GZI
Stimulator, Neuromuscular, External Functional
159d
Cleared
Apr 30, 2013
NEUROSTAR TMS THERAPY SYSTEM
OBP
Transcranial Magnetic Stimulator
90d
Cleared
Apr 26, 2013
STERILE RADIOLUCENT SKULL PINS
HBL
Holder, Head, Neurosurgical (skull Clamp)
275d
Cleared
Apr 26, 2013
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
GWN
Nystagmograph
88d
Cleared
Apr 24, 2013
DE48-PLUS
GXY
Electrode, Cutaneous
126d
Cleared
Apr 23, 2013
NUVASIVE NVM5 SYSTEM
PDQ
Neurosurgical Nerve Locator
181d
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