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
4713 Neurology devices
Cleared
Jul 05, 2017
g.Nautilus PRO
GWL
Amplifier, Physiological Signal
30d
Cleared
Jul 01, 2017
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
MOF
Guide, Wire, Catheter, Neurovasculature
30d
Cleared
Jun 30, 2017
Smart External Drain (SED) System
JXG
Shunt, Central Nervous System And Components
30d
Cleared
Jun 28, 2017
Livia
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
230d
Cleared
Jun 27, 2017
OWL RF INSULATED CANNULAE
GXI
Probe, Radiofrequency Lesion
111d
Cleared
Jun 26, 2017
SpringTMS
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
265d
Cleared
Jun 26, 2017
Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit
NHI
Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
90d
Cleared
Jun 21, 2017
ImPACT Quick Test
POM
Computerized Cognitive Assessment Aid For Concussion
117d
Cleared
Jun 16, 2017
MagVita TMS Therapy System
OBP
Transcranial Magnetic Stimulator
28d
Cleared
Jun 15, 2017
AccuPoint Electrode
GZL
Electrode, Depth
286d
Cleared
Jun 05, 2017
ElectroTek
GWQ
Full-montage Standard Electroencephalograph
111d
Cleared
Jun 02, 2017
Enobio Wireless EEG
GWQ
Full-montage Standard Electroencephalograph
249d
Cleared
Jun 02, 2017
Galvanic Spa, Model: SKB-1405
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
172d
Cleared
Jun 01, 2017
Reinforced Flexible Collagen Nerve Cuff
JXI
Cuff, Nerve
90d
Cleared
May 30, 2017
gammaCore-S
PKR
Non-invasive Vagus Nerve Stimulator - Headache
27d
Cleared
May 26, 2017
IQ Technologies
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
84d
Cleared
May 25, 2017
MultiGen™ 2 RF Generator System
GXD
Generator, Lesion, Radiofrequency
119d
Cleared
May 19, 2017
OsteoMed PINNACLE Driver
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
249d
Cleared
May 19, 2017
Nihon Kohden QP-160AK EEG Trend Program
OMA
Amplitude-integrated Electroencephalograph
147d
Cleared
May 19, 2017
Stryker Universal Neuro III System AXS Screw
HBW
Fastener, Plate, Cranioplasty
29d
Cleared
May 17, 2017
Test of Variables of Attention (T.O.V.A.) Version 9.0
LQD
Recorder, Attention Task Performance
127d
Cleared
May 16, 2017
KARL STORZ ShuntScope
GWG
Endoscope, Neurological
90d
Cleared
May 15, 2017
IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
HBC
Motor, Drill, Electric
103d
Cleared
May 12, 2017
Avazzia
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
259d
Cleared
May 11, 2017
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
108d
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