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
4748 Neurology devices
Cleared
Jun 28, 2001
NEUROPACK MICRO, MODEL MED-9100A SERIES
IKN
Electromyograph, Diagnostic
121d
Cleared
Jun 27, 2001
A-LINE AEP MONITOR
OLW
Index-generating Electroencephalograph Software
86d
Cleared
Jun 22, 2001
NEUROGEN NERVE GUIDE
JXI
Cuff, Nerve
66d
Cleared
Jun 22, 2001
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
30d
Cleared
Jun 15, 2001
EEG MIS MONITOR MODEL # A-2000
OLW
Index-generating Electroencephalograph Software
28d
Cleared
Jun 12, 2001
MULTI-STIM, MODEL MS-100
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
356d
Cleared
Jun 12, 2001
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
140d
Cleared
May 23, 2001
KM-30 TENS ELECTRODE
GXY
Electrode, Cutaneous
89d
Cleared
May 21, 2001
VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT
HAW
Neurological Stereotaxic Instrument
182d
Cleared
May 17, 2001
STEREOTACTIC FRAME BASED SYSTEM
HAW
Neurological Stereotaxic Instrument
185d
Cleared
May 15, 2001
DYNATRON STS
LIH
Interferential Current Therapy
78d
Cleared
May 15, 2001
DYNATRON STS RX
LIH
Interferential Current Therapy
47d
Cleared
May 08, 2001
NEUROFAX, MODELS EEG-1100A, EEG-9100A
OLV
Standard Polysomnograph With Electroencephalograph
19d
Cleared
May 03, 2001
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
GXD
Generator, Lesion, Radiofrequency
259d
Cleared
May 02, 2001
MACROPORENS CRANILOC
GXR
Cover, Burr Hole
274d
Cleared
Apr 20, 2001
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
GXD
Generator, Lesion, Radiofrequency
18d
Cleared
Apr 09, 2001
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
GWQ
Full-montage Standard Electroencephalograph
88d
Cleared
Apr 02, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
GWF
Stimulator, Electrical, Evoked Response
81d
Cleared
Mar 26, 2001
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
GWQ
Full-montage Standard Electroencephalograph
74d
Cleared
Mar 26, 2001
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
GWQ
Full-montage Standard Electroencephalograph
74d
Cleared
Mar 26, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
GWF
Stimulator, Electrical, Evoked Response
74d
Cleared
Mar 19, 2001
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
GWF
Stimulator, Electrical, Evoked Response
67d
Cleared
Mar 16, 2001
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
GWQ
Full-montage Standard Electroencephalograph
64d
Cleared
Mar 15, 2001
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
63d
Cleared
Mar 15, 2001
LORENZ FIDUCAIL SCREW
HAW
Neurological Stereotaxic Instrument
30d
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