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
4732 Neurology devices
Cleared
Jun 06, 2006
VECTORVISION SPINE
HAW
Neurological Stereotaxic Instrument
204d
Cleared
May 31, 2006
INSPIRSTAR GLOVE ELECTRODE
GXY
Electrode, Cutaneous
16d
Cleared
May 30, 2006
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
GYC
Electrode, Cortical
179d
Cleared
May 30, 2006
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
GXZ
Electrode, Needle
126d
Cleared
May 30, 2006
REFA, PHYSIOLOGICAL AMPLIFIER
GWL
Amplifier, Physiological Signal
106d
Cleared
May 25, 2006
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
GZL
Electrode, Depth
174d
Cleared
May 25, 2006
MODIFIED MERCI RETRIEVER, MODEL 90092
NRY
Catheter, Thrombus Retriever
38d
Cleared
May 23, 2006
ORTHOMON
GWF
Stimulator, Electrical, Evoked Response
32d
Cleared
May 10, 2006
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
GWM
Device, Monitoring, Intracranial Pressure
170d
Cleared
May 10, 2006
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
LIH
Interferential Current Therapy
30d
Cleared
May 10, 2006
RHYTHMLINK DISC ELECTRODES
GXY
Electrode, Cutaneous
15d
Cleared
May 05, 2006
INFREX
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
94d
Cleared
May 02, 2006
CMA CEREBRAL TISSUE MONITORING SYSTEM
GWM
Device, Monitoring, Intracranial Pressure
62d
Cleared
May 02, 2006
COSMAN CSK RF CANNULA
GXI
Probe, Radiofrequency Lesion
39d
Cleared
May 02, 2006
G.USBAMP
GWL
Amplifier, Physiological Signal
39d
Cleared
Apr 28, 2006
LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
88d
Cleared
Apr 28, 2006
NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
HAW
Neurological Stereotaxic Instrument
77d
Cleared
Apr 26, 2006
COOLGARD 3000
NCX
System, Hypothermia, Intravenous, Cooling
78d
Cleared
Apr 25, 2006
LESIONPOINT RF CANNULA
GXI
Probe, Radiofrequency Lesion
139d
Cleared
Apr 21, 2006
XLTEK EMU40 EEG HEADBOX, MODEL PK1072
GWQ
Full-montage Standard Electroencephalograph
137d
Cleared
Apr 20, 2006
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
HCG
Device, Neurovascular Embolization
42d
Cleared
Apr 13, 2006
NORIAN CRS FAST SET PUTTY
GXP
Methyl Methacrylate For Cranioplasty
51d
Cleared
Apr 13, 2006
NORIAN CRS BONE CEMENT
GXP
Methyl Methacrylate For Cranioplasty
51d
Cleared
Apr 12, 2006
NEUROPROBES
GZL
Electrode, Depth
212d
Cleared
Apr 10, 2006
SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
HAW
Neurological Stereotaxic Instrument
111d
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