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
4725 Neurology devices
Cleared
Apr 22, 2010
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
HCG
Device, Neurovascular Embolization
64d
Cleared
Apr 14, 2010
SYNTHES AIR PEN DRIVE (APD) SYSTEM
HBB
Motor, Drill, Pneumatic
168d
Cleared
Mar 31, 2010
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
HAW
Neurological Stereotaxic Instrument
55d
Cleared
Mar 30, 2010
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
232d
Cleared
Mar 26, 2010
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
GWF
Stimulator, Electrical, Evoked Response
269d
Cleared
Mar 10, 2010
FIXIT HEADREST CLAMP SYSTEM
HBL
Holder, Head, Neurosurgical (skull Clamp)
443d
Cleared
Feb 17, 2010
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
HAE
Rongeur, Manual
209d
Cleared
Feb 05, 2010
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
234d
Cleared
Feb 04, 2010
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
HCG
Device, Neurovascular Embolization
122d
Cleared
Jan 22, 2010
OSV II LOW FLOW LOW PRO VALVE
JXG
Shunt, Central Nervous System And Components
30d
Cleared
Jan 21, 2010
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
GXQ
Dura Substitute
169d
Cleared
Jan 21, 2010
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
HCG
Device, Neurovascular Embolization
30d
Cleared
Jan 15, 2010
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
HCG
Device, Neurovascular Embolization
79d
Cleared
Jan 13, 2010
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
IKT
Electrode, Needle, Diagnostic Electromyograph
30d
Cleared
Dec 23, 2009
SWIFT-LOCK ANCHOR, MODEL 1192
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
140d
Cleared
Dec 22, 2009
DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE
GXY
Electrode, Cutaneous
189d
Cleared
Dec 07, 2009
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
GXY
Electrode, Cutaneous
87d
Cleared
Nov 19, 2009
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
JXG
Shunt, Central Nervous System And Components
106d
Cleared
Oct 23, 2009
BIS QUATRO SENSOR
GXY
Electrode, Cutaneous
14d
Cleared
Oct 16, 2009
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
GXI
Probe, Radiofrequency Lesion
73d
Cleared
Oct 08, 2009
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
LIH
Interferential Current Therapy
29d
Cleared
Sep 30, 2009
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
HCG
Device, Neurovascular Embolization
30d
Cleared
Sep 21, 2009
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054
NRY
Catheter, Thrombus Retriever
185d
Cleared
Sep 08, 2009
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
HCH
Clip, Aneurysm
70d
Cleared
Sep 02, 2009
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
JXG
Shunt, Central Nervous System And Components
121d
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