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
4749 Neurology devices
Cleared
Jun 30, 2000
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
OLW
Index-generating Electroencephalograph Software
88d
Cleared
Jun 30, 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
GWF
Stimulator, Electrical, Evoked Response
86d
Cleared
Jun 30, 2000
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
GWQ
Full-montage Standard Electroencephalograph
86d
Cleared
Jun 27, 2000
MODIFICATION TO NC-STAT
JXE
Device, Nerve Conduction Velocity Measurement
126d
Cleared
Jun 16, 2000
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
OLT
Non-normalizing Quantitative Electroencephalograph Software
88d
Cleared
Jun 07, 2000
SELF ADHERING NAVIGUS GUIDE
HAW
Neurological Stereotaxic Instrument
56d
Cleared
Jun 07, 2000
ENDOR 2000
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
548d
Cleared
May 17, 2000
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
HAW
Neurological Stereotaxic Instrument
9d
Cleared
May 16, 2000
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
OLV
Standard Polysomnograph With Electroencephalograph
48d
Cleared
May 11, 2000
MODEL 4300 PSARRAY EEG ELECTRODE SET
GXY
Electrode, Cutaneous
38d
Cleared
May 03, 2000
GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4
HCG
Device, Neurovascular Embolization
29d
Cleared
May 02, 2000
SHELHIGH NO-REACT DURA SHIELD
GXQ
Dura Substitute
687d
Cleared
Apr 28, 2000
MEDTRONIC MODEL 7499 EXTENSION
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
78d
Cleared
Apr 26, 2000
VITAPORT 3
OLV
Standard Polysomnograph With Electroencephalograph
83d
Cleared
Apr 26, 2000
EMBOSPHERE MICROSPHERES
HCG
Device, Neurovascular Embolization
359d
Cleared
Apr 20, 2000
CRANIAL DRILL
HBB
Motor, Drill, Pneumatic
90d
Cleared
Apr 14, 2000
EEG WITH VIDEO, MODEL EX-NW
GWQ
Full-montage Standard Electroencephalograph
24d
Cleared
Apr 12, 2000
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
89d
Cleared
Apr 07, 2000
SIPHONGUARD CSF CONTROL DEVICE
JXG
Shunt, Central Nervous System And Components
284d
Cleared
Mar 30, 2000
PACIFIC SURGICAL PATTIES
HBA
Neurosurgical Paddie
204d
Cleared
Mar 27, 2000
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
GXD
Generator, Lesion, Radiofrequency
560d
Cleared
Mar 21, 2000
NEUROTHERM RF CANNULA
GXI
Probe, Radiofrequency Lesion
90d
Cleared
Mar 20, 2000
RADIONICS LUMBOPERITONEAL SHUNT
JXG
Shunt, Central Nervous System And Components
70d
Cleared
Mar 16, 2000
RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
79d
Cleared
Mar 13, 2000
CODMAN ETHISORB DURA PATCH
GXQ
Dura Substitute
325d
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