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
4716 Neurology devices
Cleared
Jan 30, 2015
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
MOF
Guide, Wire, Catheter, Neurovasculature
214d
Cleared
Jan 23, 2015
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle
PDQ
Neurosurgical Nerve Locator
81d
Cleared
Jan 21, 2015
Myoscience iovera system
GXH
Device, Surgical, Cryogenic
112d
Cleared
Jan 20, 2015
Zmachine
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
112d
Cleared
Jan 16, 2015
COLLAGEN DURA MEMBRANE
GXQ
Dura Substitute
214d
Cleared
Jan 14, 2015
Medical Monofilament Sensory Screening Toool
GXB
Esthesiometer
82d
Cleared
Jan 06, 2015
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
JXG
Shunt, Central Nervous System And Components
291d
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
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