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
6235
Total
6180
Cleared
154d
Avg (2y)
1976
Since
1726 Neurology devices
Cleared
Feb 03, 2021
Jiajian Self-Adhesive Electrode
GXY
Electrode, Cutaneous
504d
Cleared
Feb 03, 2021
AXUS ES-5 Electro-Acupuncture Device
BWK
Stimulator, Electro-acupuncture
330d
Cleared
Jan 29, 2021
Disposable Pre-calibrated Suction
HAW
Neurological Stereotaxic Instrument
217d
Cleared
Jan 29, 2021
MAGIC Infusion Catheter
KRA
Catheter, Continuous Flush
163d
Cleared
Jan 28, 2021
BOSS 8F Balloon Guide Catheter
QJP
Catheter, Percutaneous, Neurovasculature
28d
Cleared
Jan 22, 2021
NuFace Trinity Plus Device
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
206d
Cleared
Jan 22, 2021
ClearPoint Array System
HAW
Neurological Stereotaxic Instrument
140d
Cleared
Jan 22, 2021
SPRINT PNS System
NHI
Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
130d
Cleared
Jan 22, 2021
Nerivio, FGD000075-4.7
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
88d
Cleared
Jan 21, 2021
DIR 800
IZI
System, X-ray, Angiographic
153d
Cleared
Jan 14, 2021
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
GZT
Retractor, Self-retaining, For Neurosurgery
120d
Cleared
Jan 13, 2021
StealthStation Cranial Software v1.3.2
HAW
Neurological Stereotaxic Instrument
30d
Cleared
Jan 02, 2021
Sparrow Therapy System
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
179d
Cleared
Dec 31, 2020
Sim&Size
PZO
Software For Visualization Of Vascular Anatomy And Intravascular Devices
136d
Cleared
Dec 30, 2020
NeuroAmp II, NeuroAmp II.5s
GWQ
Full-montage Standard Electroencephalograph
411d
Cleared
Dec 29, 2020
First Relief v1
QHH
Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)
90d
Cleared
Dec 29, 2020
Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
57d
Cleared
Dec 27, 2020
8-CH Electroencephalography Amplifier
GWL
Amplifier, Physiological Signal
184d
Cleared
Dec 25, 2020
ImPACT Version 4
POM
Computerized Cognitive Assessment Aid For Concussion
116d
Cleared
Dec 23, 2020
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
GXH
Device, Surgical, Cryogenic
281d
Cleared
Dec 23, 2020
Scrambler Therapy Technology (Model ST-5A)
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
205d
Cleared
Dec 22, 2020
EZTrack
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
166d
Cleared
Dec 22, 2020
actiTENS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
141d
Cleared
Dec 22, 2020
Everyway Analog OTC TENS, model N103A/N302
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
85d
Cleared
Dec 22, 2020
COOLIEF Cooled Radiofrequency Kit Advanced
GXI
Probe, Radiofrequency Lesion
74d
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