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
Jun 30, 2011
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
OMC
Reduced- Montage Standard Electroencephalograph
85d
Cleared
Jun 29, 2011
WAVEGUARD (TM) EEG CAP
GXY
Electrode, Cutaneous
155d
Cleared
Jun 24, 2011
EPIDUCER LEAD DELIVERY SYSTEM
LHG
Electrode, Spinal Epidural
113d
Cleared
Jun 24, 2011
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
GXN
Plate, Cranioplasty, Preformed, Non-alterable
105d
Cleared
Jun 20, 2011
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
LIH
Interferential Current Therapy
118d
Cleared
Jun 17, 2011
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
IKT
Electrode, Needle, Diagnostic Electromyograph
57d
Cleared
Jun 03, 2011
IPLAN
HAW
Neurological Stereotaxic Instrument
359d
Cleared
Jun 03, 2011
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
GXY
Electrode, Cutaneous
266d
Cleared
May 09, 2011
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
JXG
Shunt, Central Nervous System And Components
52d
Cleared
May 05, 2011
TITAN
GWJ
Stimulator, Auditory, Evoked Response
133d
Cleared
May 05, 2011
OWL RF PROBES
GXI
Probe, Radiofrequency Lesion
64d
Cleared
Apr 29, 2011
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
GZI
Stimulator, Neuromuscular, External Functional
165d
Cleared
Apr 28, 2011
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
HCG
Device, Neurovascular Embolization
126d
Cleared
Apr 18, 2011
AOI CRANIAL HELMET
MVA
Orthosis, Cranial
152d
Cleared
Apr 14, 2011
KELYNIAM CUSTOM SKULL IMPLANT (CSI)
GXN
Plate, Cranioplasty, Preformed, Non-alterable
127d
Cleared
Apr 08, 2011
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP
MVV
Device, Acupressure
39d
Cleared
Apr 05, 2011
RT200
GZI
Stimulator, Neuromuscular, External Functional
139d
Cleared
Apr 04, 2011
RT600
GZI
Stimulator, Neuromuscular, External Functional
139d
Not Cleared
Mar 31, 2011
MANDOMETER III
OBV
Eating Disorder Conditioning Tool
1380d
Cleared
Mar 11, 2011
HEAD FIATION DEVICE (HFD 100)
HBL
Holder, Head, Neurosurgical (skull Clamp)
102d
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
Jan 26, 2011
PENUMBRA EMBOLIZATION COIL SYSTEM
HCG
Device, Neurovascular Embolization
78d
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