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
Aug 25, 2017
Nihon Kohden Wireless Input Unit WEE-1200
GWQ
Full-montage Standard Electroencephalograph
130d
Cleared
Aug 21, 2017
Ceribell Instant EEG Headband
GXY
Electrode, Cutaneous
95d
Cleared
Aug 18, 2017
QEVO System with KINEVO 900
GWG
Endoscope, Neurological
165d
Cleared
Aug 18, 2017
Relievant Medsystems RF Generator
GXD
Generator, Lesion, Radiofrequency
122d
Cleared
Aug 14, 2017
Artemis Neuro Evacuation Device
GWG
Endoscope, Neurological
98d
Cleared
Aug 11, 2017
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
270d
Cleared
Aug 09, 2017
INTRACEPT Intraosseous Nerve Ablation System
GXI
Probe, Radiofrequency Lesion
142d
Cleared
Aug 08, 2017
AxoGen Nerve Cap
JXI
Cuff, Nerve
243d
Cleared
Aug 04, 2017
Hi-Dow Wireless TENS/EMS System (Model HD-5N)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
245d
Cleared
Aug 04, 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
87d
Cleared
Jul 31, 2017
NuBODY Skin Toning Device
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
61d
Cleared
Jul 25, 2017
MagVita TMS Therapy System
OBP
Transcranial Magnetic Stimulator
25d
Cleared
Jul 19, 2017
POD Packing Coil
HCG
Device, Neurovascular Embolization
119d
Cleared
Jul 18, 2017
ES2 Neuromonitoring Accessory Instruments
PDQ
Neurosurgical Nerve Locator
29d
Cleared
Jul 14, 2017
ViMove2
IKN
Electromyograph, Diagnostic
247d
Cleared
Jul 14, 2017
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
HCG
Device, Neurovascular Embolization
31d
Cleared
Jul 11, 2017
RT300 FES cycle ergometer
GZI
Stimulator, Neuromuscular, External Functional
308d
Cleared
Jul 06, 2017
MPR2 logO DATALOGGER
GWM
Device, Monitoring, Intracranial Pressure
31d
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
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