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
4726 Neurology devices
Cleared
Aug 03, 2009
LIFECARE ELECTRODES
GXY
Electrode, Cutaneous
266d
Cleared
Jul 28, 2009
PMT HALO SYSTEM
HAX
Tong, Skull For Traction
131d
Cleared
Jul 17, 2009
STARLIGHT
OAN
Orthosis, Cranial, Laser Scan
135d
Cleared
Jul 16, 2009
SMITH & NEPHEW RF CANNULATE
GXI
Probe, Radiofrequency Lesion
101d
Cleared
Jul 02, 2009
BIS CLICK SENSOR/CABLE
GXY
Electrode, Cutaneous
13d
Cleared
Jun 30, 2009
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
HCG
Device, Neurovascular Embolization
26d
Cleared
Jun 25, 2009
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
52d
Cleared
Jun 23, 2009
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
IKT
Electrode, Needle, Diagnostic Electromyograph
71d
Cleared
Jun 23, 2009
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
IKT
Electrode, Needle, Diagnostic Electromyograph
71d
Cleared
Jun 22, 2009
MICROPLEX COIL SYSTEM-COSMOS
HCG
Device, Neurovascular Embolization
84d
Cleared
Jun 08, 2009
NUVASIVE NEURO VISION SYSTEM
GWF
Stimulator, Electrical, Evoked Response
122d
Cleared
Jun 05, 2009
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
65d
Cleared
Jun 02, 2009
PENTA LEAD KITS, MODELS: 3227-3234
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
62d
Cleared
Jun 02, 2009
CODMAN HAKIM MICRO II VALVE
JXG
Shunt, Central Nervous System And Components
26d
Cleared
May 27, 2009
NEUROMETRIX BIOAMPLIFIER
GWL
Amplifier, Physiological Signal
196d
Cleared
May 08, 2009
CRANIAL IMAGE GUIDED SURGERY SYSTEM
HAW
Neurological Stereotaxic Instrument
291d
Cleared
May 08, 2009
PMT SUBDURAL CORTICAL ELECTRODES
GYC
Electrode, Cortical
253d
Cleared
May 01, 2009
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
HAW
Neurological Stereotaxic Instrument
445d
Cleared
Apr 29, 2009
PRIMADO
HBC
Motor, Drill, Electric
190d
Cleared
Apr 20, 2009
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
HBL
Holder, Head, Neurosurgical (skull Clamp)
54d
Cleared
Apr 10, 2009
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
GXY
Electrode, Cutaneous
262d
Cleared
Apr 10, 2009
HYDROFRAME (HES)
HCG
Device, Neurovascular Embolization
57d
Cleared
Mar 18, 2009
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
GZT
Retractor, Self-retaining, For Neurosurgery
42d
Cleared
Mar 12, 2009
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
HCG
Device, Neurovascular Embolization
48d
Cleared
Mar 11, 2009
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
219d
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