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
Nov 23, 2011
PENUMBRA SYSTEM MAX
NRY
Catheter, Thrombus Retriever
28d
Cleared
Nov 18, 2011
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
JXG
Shunt, Central Nervous System And Components
263d
Cleared
Nov 17, 2011
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
107d
Cleared
Nov 10, 2011
BMR FACE
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
394d
Cleared
Nov 10, 2011
X-FORCE
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
160d
Cleared
Nov 09, 2011
FD TENS 2050 OR SLIDE TENS MODEL FD2050
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
149d
Cleared
Nov 07, 2011
NUFACE PLUS
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
348d
Cleared
Oct 28, 2011
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
GWQ
Full-montage Standard Electroencephalograph
98d
Cleared
Oct 27, 2011
AESCULAP- MEITHKE SHUNT SYSTEM
JXG
Shunt, Central Nervous System And Components
275d
Cleared
Oct 27, 2011
REHASTIM 2, REHAMOVE 2
GZI
Stimulator, Neuromuscular, External Functional
28d
Cleared
Oct 26, 2011
IPC POWEREASE SYSTEM
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
146d
Cleared
Oct 21, 2011
LIFECARE ARM & LEG PAIN RELIEF SYSTEM
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
60d
Cleared
Oct 20, 2011
QUADRA BLOC TENS PLUS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
435d
Cleared
Oct 20, 2011
NEUROLAC(R) NERVE GUIDE
JXI
Cuff, Nerve
73d
Cleared
Oct 18, 2011
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
217d
Cleared
Oct 17, 2011
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
JXG
Shunt, Central Nervous System And Components
82d
Cleared
Oct 14, 2011
DISPOSABLE ELECTRODE
GXY
Electrode, Cutaneous
115d
Cleared
Oct 11, 2011
RAUMEDIC ICP MONITORING SYSTEM
GWM
Device, Monitoring, Intracranial Pressure
89d
Cleared
Oct 06, 2011
ERASE HAND- HELD CONTROLLER
GXD
Generator, Lesion, Radiofrequency
486d
Cleared
Oct 06, 2011
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
GWF
Stimulator, Electrical, Evoked Response
115d
Cleared
Sep 30, 2011
NEUROVISION NERVE LOCATOR MONITOR
GWF
Stimulator, Electrical, Evoked Response
255d
Cleared
Sep 29, 2011
EMG SYSTEM
HCC
Device, Biofeedback
105d
Cleared
Sep 29, 2011
HYDROCOIL EMBOLIC SYSTEM (HES)
HCG
Device, Neurovascular Embolization
57d
Cleared
Sep 20, 2011
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
HCG
Device, Neurovascular Embolization
118d
Cleared
Sep 20, 2011
NT 2000 LESIONING GENERATOR
GXD
Generator, Lesion, Radiofrequency
106d
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