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
554 Neurology devices
Cleared
Oct 26, 2023
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP)
GXH
Device, Surgical, Cryogenic
29d
Cleared
Oct 25, 2023
Penumbra LP Coil System
HCG
Device, Neurovascular Embolization
265d
Cleared
Oct 25, 2023
Magstim®Horizon® 3.0 TMS Therapy System
OBP
Transcranial Magnetic Stimulator
90d
Cleared
Oct 19, 2023
StealthStation Cranial Software, v3.1.5 (9735585)
HAW
Neurological Stereotaxic Instrument
108d
Cleared
Oct 12, 2023
MONTAGE-QS Settable, Resorbable Bone Putty
GXP
Methyl Methacrylate For Cranioplasty
143d
Cleared
Oct 06, 2023
EARP Nerve Cuff Electrode
ETN
Stimulator, Nerve
192d
Cleared
Oct 05, 2023
Heating Tens, FT-615
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
34d
Cleared
Sep 21, 2023
QEVO System
GWG
Endoscope, Neurological
63d
Cleared
Sep 18, 2023
BTL-785BNF Handpiece
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
59d
Cleared
Sep 15, 2023
ClearPoint Array System (Version 1.2)
HAW
Neurological Stereotaxic Instrument
63d
Cleared
Sep 14, 2023
SOFIA EX Intracranial Support Catheter
QJP
Catheter, Percutaneous, Neurovasculature
177d
Cleared
Sep 13, 2023
NG Delivery Catheter
QJP
Catheter, Percutaneous, Neurovasculature
191d
Cleared
Sep 09, 2023
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
HAW
Neurological Stereotaxic Instrument
260d
Cleared
Sep 08, 2023
STarFix Designer Software C0265
QRI
Surgical Planning Software For Neurological Stereotaxic Instruments
140d
Cleared
Aug 18, 2023
Unicare (K-UNICARE-USA)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
127d
Cleared
Aug 17, 2023
Cadwell Guardian
GWF
Stimulator, Electrical, Evoked Response
182d
Cleared
Aug 15, 2023
Route 92 Medical Full Length 054 Access System
QJP
Catheter, Percutaneous, Neurovasculature
76d
Cleared
Aug 14, 2023
Stryker Resorbable Fixation System
HBW
Fastener, Plate, Cranioplasty
109d
Cleared
Aug 09, 2023
Conductive carbon film electrode
GXY
Electrode, Cutaneous
106d
Cleared
Aug 09, 2023
Conductive Silicone Rubber Electrode
GXY
Electrode, Cutaneous
106d
Cleared
Aug 08, 2023
Ceribell Instant EEG Headband
GXY
Electrode, Cutaneous
29d
Cleared
Jul 21, 2023
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
HAW
Neurological Stereotaxic Instrument
269d
Cleared
Jun 29, 2023
SQ.line KERRISON
HAE
Rongeur, Manual
209d
Cleared
May 26, 2023
Cerebral Adaptive Index (CAI) Algorithm
MUD
Oximeter, Tissue Saturation
171d
Cleared
May 23, 2023
Ceribell Status Epilepticus Monitor
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
182d
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