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
6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
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
Cleared
May 08, 2017
Ceribell Pocket EEG Device
OMC
Reduced- Montage Standard Electroencephalograph
91d
Cleared
May 08, 2017
Adhesive Electrodes
GXY
Electrode, Cutaneous
59d
Cleared
May 05, 2017
Internal Distraction - Sterile
PBJ
Cranial Distraction System
163d
Cleared
May 02, 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
105d
Cleared
May 01, 2017
MagVita TMS Therapy - w/MagPro R20
OBP
Transcranial Magnetic Stimulator
109d
Cleared
Apr 29, 2017
Digital TENS Unit
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
102d
Cleared
Apr 28, 2017
WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
GXY
Electrode, Cutaneous
238d
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