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
4753 Neurology devices
Cleared
May 17, 1996
FOCUS MODEL 795 UNIT
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
387d
Cleared
May 17, 1996
DUALSCREEN
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
183d
Cleared
May 17, 1996
UNIVERSAL BITE BLOCK
JXL
Block, Bite
91d
Cleared
May 17, 1996
TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
GZT
Retractor, Self-retaining, For Neurosurgery
79d
Cleared
May 16, 1996
MAGNES II BIOMAGNETOMETER
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
778d
Cleared
May 16, 1996
MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
HBB
Motor, Drill, Pneumatic
300d
Cleared
May 15, 1996
GALVA 5-T
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
65d
Cleared
May 10, 1996
NEURO-PATCH
GXQ
Dura Substitute
99d
Cleared
May 10, 1996
MARKER SYSTEM FOR STEREOTAXIC NAVIGATION
HAW
Neurological Stereotaxic Instrument
50d
Cleared
May 10, 1996
EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
GXY
Electrode, Cutaneous
50d
Cleared
May 10, 1996
MODEL 1220, OR E-NET (54-62 CM)
GXY
Electrode, Cutaneous
15d
Cleared
May 07, 1996
GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL
GYB
Media, Electroconductive
596d
Cleared
May 07, 1996
GRAHAM-FIELD CONDUCTIVE ECG SPRAY
GYB
Media, Electroconductive
596d
Cleared
Apr 30, 1996
MAYFIELD-ACCISS WORKSTATION
HAW
Neurological Stereotaxic Instrument
158d
Cleared
Apr 26, 1996
SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
HCH
Clip, Aneurysm
91d
Cleared
Apr 26, 1996
MODEL 1210, MEDIUM E-NET
GXY
Electrode, Cutaneous
53d
Cleared
Apr 26, 1996
MODEL 1240, SMALL E NET
GXY
Electrode, Cutaneous
53d
Cleared
Apr 17, 1996
AT53 DUAL CHANNEL EMG
HCC
Device, Biofeedback
303d
Cleared
Apr 15, 1996
EVOKED POTENTIAL SYSTEM-1.0
GWF
Stimulator, Electrical, Evoked Response
1032d
Cleared
Apr 15, 1996
HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500
GXY
Electrode, Cutaneous
53d
Cleared
Apr 11, 1996
DISPOSABLE NEUROVIEW INTRODUCER SHEATH
GWG
Endoscope, Neurological
44d
Cleared
Apr 04, 1996
HARMONIE SENSA
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
76d
Cleared
Mar 25, 1996
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
GXZ
Electrode, Needle
424d
Cleared
Mar 25, 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
JXG
Shunt, Central Nervous System And Components
90d
Cleared
Mar 22, 1996
LEKSELL NEURO GENERATOR AND ACCESSORIES
GXD
Generator, Lesion, Radiofrequency
709d
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