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
4752 Neurology devices
Cleared
May 19, 1997
VIEWPOINT - 3.0 SOFTWARE
HAW
Neurological Stereotaxic Instrument
90d
Cleared
May 19, 1997
LUMBAR DRAINAGE ACCESSORY KIT
JXG
Shunt, Central Nervous System And Components
87d
Cleared
May 19, 1997
GALILEO HALLEY
GWQ
Full-montage Standard Electroencephalograph
82d
Cleared
May 19, 1997
GRASS BRAINWAVE SOFTWARE
OLV
Standard Polysomnograph With Electroencephalograph
66d
Cleared
May 16, 1997
DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
GYE
Encephalogram Telemetry System
84d
Cleared
May 15, 1997
NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K
GXY
Electrode, Cutaneous
84d
Cleared
May 14, 1997
MODEL 1700, HYDRO PREP
GYB
Media, Electroconductive
78d
Cleared
May 09, 1997
NEUROMATE STEREOTACTIC SYSTEM
HAW
Neurological Stereotaxic Instrument
263d
Cleared
May 09, 1997
AD-TECH'S DEPTH ELECTRODE
GZL
Electrode, Depth
190d
Cleared
May 09, 1997
VALUETRODE
GXY
Electrode, Cutaneous
94d
Cleared
May 09, 1997
AD-TECH SUBDURAL ELECTRODE
GYC
Electrode, Cortical
80d
Cleared
May 07, 1997
MAGNES 2500 WH BIOMAGNETOMETER
OLY
Magnetoencephalograph
324d
Cleared
May 02, 1997
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
HBA
Neurosurgical Paddie
288d
Cleared
May 02, 1997
DIGIT-GRIP WITH LCD (DGR002)
HRW
Dynamometer, Nonpowered
53d
Cleared
Apr 29, 1997
PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
GZL
Electrode, Depth
84d
Cleared
Apr 29, 1997
BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
84d
Cleared
Apr 25, 1997
SIMPLEX TENS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
611d
Cleared
Apr 25, 1997
VSA 3000 VIBRATORYN SENSORY ANALYZER
LLN
Device, Vibration Threshold Measurement
98d
Cleared
Apr 23, 1997
SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
HAW
Neurological Stereotaxic Instrument
121d
Cleared
Apr 21, 1997
AESCULAP ANGLED NEUROENDOSCOPES
GWG
Endoscope, Neurological
175d
Cleared
Apr 21, 1997
ULTRACELL NEURO SPONGES
HBA
Neurosurgical Paddie
84d
Cleared
Apr 14, 1997
EPIX VT
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
83d
Cleared
Apr 02, 1997
SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
203d
Cleared
Apr 01, 1997
APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE
LIH
Interferential Current Therapy
659d
Cleared
Mar 27, 1997
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
HCG
Device, Neurovascular Embolization
171d
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