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
4696 Neurology devices
Cleared
May 25, 2022
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
86d
Cleared
May 20, 2022
iovera System
GXH
Device, Surgical, Cryogenic
74d
Cleared
May 19, 2022
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
HBC
Motor, Drill, Electric
91d
Not Cleared
May 18, 2022
Quell-FM
QSQ
Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
225d
Cleared
May 17, 2022
Imperative Care Radial 088 Access System
QJP
Catheter, Percutaneous, Neurovasculature
60d
Cleared
May 13, 2022
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
GZT
Retractor, Self-retaining, For Neurosurgery
438d
Cleared
May 12, 2022
ANSiStim-PP
NHI
Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
90d
Cleared
May 11, 2022
Wireless EEG System
OLT
Non-normalizing Quantitative Electroencephalograph Software
222d
Cleared
May 06, 2022
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
QCI
Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
289d
Cleared
May 06, 2022
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
151d
Cleared
May 06, 2022
Disposable EEG cable
GXY
Electrode, Cutaneous
144d
Cleared
May 06, 2022
WAVi SCAN EEG System and Accessories
GWQ
Full-montage Standard Electroencephalograph
143d
Cleared
May 05, 2022
Spartan SC 069
DQY
Catheter, Percutaneous
55d
Cleared
May 04, 2022
ROSA ONE Brain application
HAW
Neurological Stereotaxic Instrument
128d
Cleared
May 02, 2022
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Apr 25, 2022
MyoCycle MC-2 (Home / Home + / Pro / Pro +)
GZI
Stimulator, Neuromuscular, External Functional
130d
Cleared
Apr 23, 2022
TENS device-EmeTerm 2, Model: YF-ZTY-E2
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
60d
Cleared
Apr 21, 2022
GEMS-H
PHL
Powered Exoskeleton
177d
Cleared
Apr 19, 2022
Brainlab Elements Guide XT, Guide 3.0
QQC
Brain Stimulation Programming Planning Software.
124d
Cleared
Apr 19, 2022
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Apr 15, 2022
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
256d
Cleared
Apr 13, 2022
Bendit21 Microcatheter
QJP
Catheter, Percutaneous, Neurovasculature
468d
Cleared
Apr 12, 2022
PROWLER SELECT LP ES Microcatheter
KRA
Catheter, Continuous Flush
111d
Cleared
Apr 12, 2022
ClearPoint Array System (version 1.1)
HAW
Neurological Stereotaxic Instrument
110d
Cleared
Apr 08, 2022
visor2 system
HAW
Neurological Stereotaxic Instrument
444d
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