FDA 510(k) Neurology Devices
About Neurology Devices
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
6214
Total
6160
Cleared
148d
Avg days
1976
Since
556 Neurology devices
Cleared
Apr 27, 2021
STARband, STARlight, St. Louis Band
OAN
Orthosis, Cranial, Laser Scan
195d
Cleared
Mar 01, 2021
Solitaire X Revascularization Device
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
105d
Cleared
Feb 09, 2021
Stryker PEEK Customized Cranial Implant Kit
GWO
Plate, Cranioplasty, Preformed, Alterable
124d
Cleared
Jan 29, 2021
Disposable Pre-calibrated Suction
HAW
Neurological Stereotaxic Instrument
217d
Cleared
Jan 21, 2021
DIR 800
IZI
System, X-ray, Angiographic
153d
Cleared
Jan 13, 2021
StealthStation Cranial Software v1.3.2
HAW
Neurological Stereotaxic Instrument
30d
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