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
6235
Total
6180
Cleared
154d
Avg (2y)
1976
Since
1746 Neurology devices
Cleared
Oct 11, 2019
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
JXG
Shunt, Central Nervous System And Components
109d
Cleared
Oct 10, 2019
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
430d
Cleared
Oct 10, 2019
Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial
PJN
Filler, Bone Void, Non-alterable Compound For Cranioplasty
220d
Cleared
Oct 10, 2019
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
IZI
System, X-ray, Angiographic
198d
Cleared
Oct 09, 2019
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
DQX
Wire, Guide, Catheter
107d
Cleared
Sep 25, 2019
Mediracer NCS
JXE
Device, Nerve Conduction Velocity Measurement
205d
Cleared
Sep 21, 2019
Medi-Direct TENS Pen
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
360d
Cleared
Sep 12, 2019
L360 Thigh System
GZI
Stimulator, Neuromuscular, External Functional
90d
Cleared
Sep 11, 2019
BrainScope TBI
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
166d
Cleared
Sep 11, 2019
Ceribell Pocket EEG Device
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
120d
Cleared
Sep 07, 2019
Focus TENS Therapy, Model PM710-M/-L
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
292d
Cleared
Sep 06, 2019
Microscope Navigation
HAW
Neurological Stereotaxic Instrument
211d
Cleared
Sep 06, 2019
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
99d
Cleared
Sep 04, 2019
Myo Plus
GXY
Electrode, Cutaneous
125d
Cleared
Aug 30, 2019
Artemis Eye System
GWG
Endoscope, Neurological
163d
Cleared
Aug 30, 2019
ReliefBand
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
79d
Cleared
Aug 30, 2019
SelectFlex 072 Neurovascular Access System
DQY
Catheter, Percutaneous
70d
Cleared
Aug 28, 2019
PureLift
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
201d
Cleared
Aug 16, 2019
GIM-STIM OTC TENS/EMS System
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
123d
Cleared
Aug 09, 2019
ELAN 4 Tools
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
263d
Cleared
Aug 05, 2019
EEG Electrode Template
GXY
Electrode, Cutaneous
90d
Cleared
Aug 02, 2019
046 Zenith Flex
NRY
Catheter, Thrombus Retriever
169d
Cleared
Aug 01, 2019
Mini TENS Therapy Device
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
293d
Cleared
Aug 01, 2019
Leksell Vantage Stereotactic System
HAW
Neurological Stereotaxic Instrument
119d
Cleared
Jul 31, 2019
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
HAW
Neurological Stereotaxic Instrument
138d
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