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
4720 Neurology devices
Cleared
Aug 01, 2013
MYOVISION 3.0 WIREFREE SYSTEM
IKN
Electromyograph, Diagnostic
269d
Cleared
Jul 25, 2013
SMARTRELIEF
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
92d
Cleared
Jul 25, 2013
BARRICADE EMBOLIZATION COIL SYSTEM
HCG
Device, Neurovascular Embolization
64d
Cleared
Jul 22, 2013
MR CONDITIONAL PRESSON ELECTRODE
GXZ
Electrode, Needle
174d
Cleared
Jul 19, 2013
T1040 AKA AURAWAVE
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
200d
Cleared
Jul 19, 2013
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
GXZ
Electrode, Needle
182d
Cleared
Jul 17, 2013
VALUTRODE NEUROSTIMLATION ELECTRODES
GXY
Electrode, Cutaneous
99d
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
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