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
Dec 30, 2014
OWL CANNULAE
GXI
Probe, Radiofrequency Lesion
200d
Cleared
Dec 24, 2014
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
HCG
Device, Neurovascular Embolization
117d
Cleared
Dec 22, 2014
SPEEDY FLAP SYSTEM
GXN
Plate, Cranioplasty, Preformed, Non-alterable
669d
Cleared
Dec 18, 2014
StimPad OTC
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
87d
Cleared
Dec 12, 2014
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
GZL
Electrode, Depth
269d
Cleared
Dec 05, 2014
NAVIGABLE BRAIN BIOPSY CANNULA SET
HAW
Neurological Stereotaxic Instrument
259d
Cleared
Dec 03, 2014
5000Z FIREFLY SYSTEM
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
384d
Cleared
Dec 03, 2014
MAXPOWER RELIEF
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
135d
Cleared
Dec 01, 2014
Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip
MVV
Device, Acupressure
89d
Cleared
Nov 25, 2014
Atricure Cryo Module System
GXH
Device, Surgical, Cryogenic
106d
Cleared
Nov 24, 2014
MAYFIELD Skull Clamp
HBL
Holder, Head, Neurosurgical (skull Clamp)
103d
Cleared
Nov 21, 2014
SUDOSCAN
GZO
Device, Galvanic Skin Response Measurement
133d
Cleared
Nov 17, 2014
ASCEND ELECTRODE
GXY
Electrode, Cutaneous
255d
Cleared
Nov 17, 2014
CUTANEOUS ELECTRODES
GXY
Electrode, Cutaneous
108d
Not Cleared
Nov 17, 2014
BrainScope Ahead 100
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
89d
Cleared
Nov 14, 2014
GARMENT ELECTRODES
GXY
Electrode, Cutaneous
203d
Cleared
Nov 14, 2014
OTC COMBO TENS/EMS SYSTEM
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
179d
Cleared
Nov 14, 2014
WEARABLE THERAPY GARMENTS
GXY
Electrode, Cutaneous
177d
Cleared
Nov 14, 2014
NUVASIVE NVM5 SYSTEM
PDQ
Neurosurgical Nerve Locator
116d
Cleared
Nov 14, 2014
MINOP Disposable Introducer 26F
GWG
Endoscope, Neurological
87d
Cleared
Nov 13, 2014
Barricade Embolization Coil System
HCG
Device, Neurovascular Embolization
66d
Cleared
Nov 12, 2014
HEALTH EXPERT ELCTRONIC STIMULATOR
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
324d
Cleared
Nov 07, 2014
PANTHEON ELECTROSTIMULATOR
BWK
Stimulator, Electro-acupuncture
315d
Cleared
Nov 07, 2014
INNOVASIS CRANIAL SYSTEM
GWO
Plate, Cranioplasty, Preformed, Alterable
141d
Not Cleared
Nov 07, 2014
ZAP-IT!
OSG
Piezo-electric Stimulator For Relief Of Mosquito Bite Itch
1520d
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