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
Mar 11, 2011
HEAD FIATION DEVICE (HFD 100)
HBL
Holder, Head, Neurosurgical (skull Clamp)
102d
Cleared
Mar 04, 2011
FOCUS EMG DEVICE
IKN
Electromyograph, Diagnostic
175d
Cleared
Mar 04, 2011
RAUMEDIC- ICP-MONITORING SYSTEM
GWM
Device, Monitoring, Intracranial Pressure
123d
Cleared
Feb 18, 2011
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS
JXG
Shunt, Central Nervous System And Components
136d
Cleared
Feb 17, 2011
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
NRY
Catheter, Thrombus Retriever
454d
Cleared
Feb 16, 2011
GDC 360 DETEACHABLE COIL
HCG
Device, Neurovascular Embolization
92d
Cleared
Feb 09, 2011
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
GZL
Electrode, Depth
37d
Cleared
Feb 07, 2011
NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
HAW
Neurological Stereotaxic Instrument
101d
Cleared
Jan 26, 2011
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
HCD
Cannula, Ventricular
183d
Cleared
Jan 26, 2011
PENUMBRA EMBOLIZATION COIL SYSTEM
HCG
Device, Neurovascular Embolization
78d
Cleared
Jan 26, 2011
CERSR ELECTROMYOGRAPHY SYSTEM
IKN
Electromyograph, Diagnostic
20d
Cleared
Jan 14, 2011
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
GWM
Device, Monitoring, Intracranial Pressure
175d
Cleared
Jan 14, 2011
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
JXG
Shunt, Central Nervous System And Components
127d
Cleared
Dec 21, 2010
GEOSOURCE
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
462d
Cleared
Dec 20, 2010
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
GWM
Device, Monitoring, Intracranial Pressure
80d
Cleared
Dec 13, 2010
FRONTIER DEVICES NEURO SYSTEM
GWO
Plate, Cranioplasty, Preformed, Alterable
322d
Cleared
Dec 10, 2010
ELECTRO INTERSTITIAL SCAN
GZO
Device, Galvanic Skin Response Measurement
130d
Cleared
Dec 10, 2010
INZONE DETACHMENT SYSTEM
HCG
Device, Neurovascular Embolization
59d
Cleared
Dec 08, 2010
NEMA-ST, MODEL V1.0.2
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
274d
Cleared
Dec 03, 2010
MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
HBW
Fastener, Plate, Cranioplasty
155d
Cleared
Dec 02, 2010
ADHESIVE ELECTRODES
GXY
Electrode, Cutaneous
64d
Cleared
Nov 24, 2010
MAX-IF1000
LIH
Interferential Current Therapy
301d
Cleared
Nov 23, 2010
INTEGRA ELECTRODE TUNNELING NEEDLE
GYC
Electrode, Cortical
57d
Cleared
Nov 18, 2010
SENSOMETRICS SOFTWARE
GWM
Device, Monitoring, Intracranial Pressure
210d
Cleared
Nov 18, 2010
MICROPLEX COIL SYSTEM- COSMOS
KRD
Device, Vascular, For Promoting Embolization
90d
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