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
4704 Neurology devices
Cleared
Feb 14, 2020
Orion LifeSpan MEG
OLY
Magnetoencephalograph
226d
Cleared
Feb 13, 2020
ClearPoint System and Accessories
HAW
Neurological Stereotaxic Instrument
30d
Cleared
Feb 07, 2020
Vesta RF Cannula
GXI
Probe, Radiofrequency Lesion
365d
Cleared
Feb 07, 2020
Elefix V Paste for EEG & EMG
GYB
Media, Electroconductive
198d
Cleared
Feb 07, 2020
Trevo NXT ProVue Retriever
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
17d
Cleared
Feb 01, 2020
Optima Coil System
HCG
Device, Neurovascular Embolization
25d
Cleared
Jan 30, 2020
Neo
OMA
Amplitude-integrated Electroencephalograph
112d
Cleared
Jan 25, 2020
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
GYC
Electrode, Cortical
267d
Cleared
Jan 24, 2020
LCCS VC-S RF Cannula
GXI
Probe, Radiofrequency Lesion
255d
Cleared
Jan 24, 2020
cortiQ PRO
OLU
Normalizing Quantitative Electroencephalograph Software
240d
Cleared
Jan 22, 2020
E-EEGX, N-EEGX
OLT
Non-normalizing Quantitative Electroencephalograph Software
252d
Cleared
Jan 21, 2020
Disposable Gold Cup EEG Electrodes
GXY
Electrode, Cutaneous
125d
Cleared
Jan 18, 2020
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
DQX
Wire, Guide, Catheter
29d
Cleared
Jan 17, 2020
SAC2 - Electrode Cream
GYB
Media, Electroconductive
119d
Cleared
Jan 17, 2020
CustomizedBone Service
GXN
Plate, Cranioplasty, Preformed, Non-alterable
28d
Cleared
Jan 13, 2020
Route 92 Medical Sheath System
DQY
Catheter, Percutaneous
201d
Cleared
Jan 09, 2020
Longeviti ClearFit Cranial Implant
GXN
Plate, Cranioplasty, Preformed, Non-alterable
248d
Cleared
Jan 03, 2020
NeuroBlate System
GEX
Powered Laser Surgical Instrument
29d
Cleared
Jan 02, 2020
Sterile LeadConfirm
GZL
Electrode, Depth
188d
Cleared
Dec 24, 2019
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
DQY
Catheter, Percutaneous
139d
Cleared
Dec 23, 2019
RIST Cath Radial Access Long Sheath
DQY
Catheter, Percutaneous
194d
Cleared
Dec 21, 2019
Spinalytics
LXM
Manipulator, Plunger-like Joint
89d
Cleared
Dec 19, 2019
Everyway OTC TENS/EMS Combination
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Dec 17, 2019
CNS Envision
OLT
Non-normalizing Quantitative Electroencephalograph Software
90d
Cleared
Dec 15, 2019
AXS Vecta Aspiration Catheter
DQY
Catheter, Percutaneous
258d
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