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
Nov 27, 2019
7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
HAW
Neurological Stereotaxic Instrument
40d
Cleared
Nov 26, 2019
NeuroOne Cortical Electrode
GYC
Electrode, Cortical
57d
Cleared
Nov 23, 2019
Cadwell Bolt Software
OLT
Non-normalizing Quantitative Electroencephalograph Software
243d
Cleared
Nov 22, 2019
Healy
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
213d
Cleared
Nov 22, 2019
Trevo Trak 21 Microcatheter
DQO
Catheter, Intravascular, Diagnostic
108d
Cleared
Nov 22, 2019
Trevo NXT ProVue Retriever
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
100d
Cleared
Nov 22, 2019
Spes Medica Subdermal Needle Electrodes
GXZ
Electrode, Needle
63d
Cleared
Nov 21, 2019
M. Blue Adjustable Shunt System
JXG
Shunt, Central Nervous System And Components
92d
Cleared
Nov 20, 2019
Penumbra LP Coil System
HCG
Device, Neurovascular Embolization
30d
Cleared
Nov 15, 2019
Arcus Head Fixation Frame
HBL
Holder, Head, Neurosurgical (skull Clamp)
143d
Cleared
Nov 15, 2019
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
JXG
Shunt, Central Nervous System And Components
84d
Cleared
Nov 13, 2019
Nox Sleep System
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
65d
Cleared
Nov 08, 2019
CERENOVUS Large Bore Catheter
DQY
Catheter, Percutaneous
184d
Cleared
Nov 07, 2019
SandShark Injectable Anchor (SIA) System
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
157d
Cleared
Nov 01, 2019
Stealth Autoguide System, Midas Rex Legend Depth Stop System
HAW
Neurological Stereotaxic Instrument
137d
Cleared
Nov 01, 2019
Combo Electrotherapy Device
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
88d
Cleared
Oct 31, 2019
StimRouter Neuromodulation System
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
295d
Cleared
Oct 31, 2019
087 Balloon Guide Catheter System
DQY
Catheter, Percutaneous
48d
Cleared
Oct 30, 2019
Aristotle 24 Guidewire, 200cm, Soft Profile
DQX
Wire, Guide, Catheter
30d
Cleared
Oct 22, 2019
DORO QR3 XTom Headholder System
HBL
Holder, Head, Neurosurgical (skull Clamp)
90d
Cleared
Oct 18, 2019
ATEC IOM Accessory Instruments
PDQ
Neurosurgical Nerve Locator
113d
Cleared
Oct 17, 2019
BcSs-PICNI-2000 Sensor
GWM
Device, Monitoring, Intracranial Pressure
442d
Cleared
Oct 15, 2019
NuFACE Mini Device
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
113d
Cleared
Oct 11, 2019
Electronic Pulse Stimulator
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
288d
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
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