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
4702 Neurology devices
Cleared
Jun 23, 2020
CUSA Clarity Ultrasonic Surgical Aspirator System
LFL
Instrument, Ultrasonic Surgical
90d
Cleared
Jun 22, 2020
Byteflies Kit
OMC
Reduced- Montage Standard Electroencephalograph
279d
Cleared
Jun 19, 2020
EksoNR
PHL
Powered Exoskeleton
106d
Cleared
Jun 18, 2020
TENS and Muscle Stimulator
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Not Cleared
Jun 15, 2020
EndeavorRx
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
60d
Cleared
Jun 12, 2020
Electrical Stimulator System
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
304d
Cleared
Jun 11, 2020
Benchmark BMX96 Access System
DQY
Catheter, Percutaneous
30d
Cleared
Jun 03, 2020
Flap Fixator, Burr Hole Cover
GXR
Cover, Burr Hole
282d
Cleared
Jun 03, 2020
StealthStation Cranial Software v1.3.0
HAW
Neurological Stereotaxic Instrument
33d
Cleared
Jun 02, 2020
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
HBL
Holder, Head, Neurosurgical (skull Clamp)
174d
Cleared
Jun 01, 2020
BRAINSTREAM Disposable Deep Cup EEG Electrodes
GXY
Electrode, Cutaneous
90d
Cleared
May 29, 2020
ROSA ONE Brain application
HAW
Neurological Stereotaxic Instrument
88d
Cleared
May 27, 2020
Guardian Needle Electrode
GXZ
Electrode, Needle
43d
Cleared
May 26, 2020
ReWalk P6.0
PHL
Powered Exoskeleton
140d
Cleared
May 26, 2020
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
GWM
Device, Monitoring, Intracranial Pressure
29d
Cleared
May 18, 2020
Natus NeuroWorks
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
46d
Cleared
May 13, 2020
Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
GXY
Electrode, Cutaneous
475d
Cleared
May 08, 2020
Ventricular Catheter
JXG
Shunt, Central Nervous System And Components
29d
Cleared
May 04, 2020
LIVIA
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
543d
Cleared
May 02, 2020
RIST Radial Access Catheter
QJP
Catheter, Percutaneous, Neurovasculature
72d
Cleared
May 02, 2020
BOSS Balloon Guide Catheter
QJP
Catheter, Percutaneous, Neurovasculature
26d
Cleared
Apr 29, 2020
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
JXG
Shunt, Central Nervous System And Components
33d
Cleared
Apr 26, 2020
MECTA Sigma
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
207d
Cleared
Apr 25, 2020
i-ED COIL
HCG
Device, Neurovascular Embolization
268d
Cleared
Apr 24, 2020
Maxxi Position Sensor
GWQ
Full-montage Standard Electroencephalograph
324d
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