FDA 510(k) Neurology Devices
About Neurology Devices
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
6214
Total
6160
Cleared
148d
Avg days
1976
Since
553 Neurology devices
Cleared
Jun 04, 2025
EVE Synergy (EVE-20M)
IPF
Stimulator, Muscle, Powered
379d
Cleared
Jun 03, 2025
Raptor Aspiration Catheter
NRY
Catheter, Thrombus Retriever
162d
Cleared
Jun 03, 2025
EVAC
JXG
Shunt, Central Nervous System And Components
245d
Cleared
May 29, 2025
Visualase V2 MRI-guided Laser Ablation System (9736422)
ONO
Neurosurgical Laser With Mr Thermography
115d
Cleared
May 29, 2025
TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
164d
Cleared
May 28, 2025
Zoom 7X Catheter
NRY
Catheter, Thrombus Retriever
243d
Cleared
May 27, 2025
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
GXI
Probe, Radiofrequency Lesion
250d
Cleared
May 23, 2025
93 NeuFlex Catheter
QJP
Catheter, Percutaneous, Neurovasculature
50d
Cleared
May 23, 2025
SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
102d
Cleared
May 23, 2025
NeuroMatch
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
116d
Cleared
May 23, 2025
Stereotaxic Guiding Surgical Devices, NaoTrac S
HAW
Neurological Stereotaxic Instrument
267d
Cleared
May 21, 2025
HJY VisualNext 3D Endoscopic Vision System
GWG
Endoscope, Neurological
197d
Cleared
May 19, 2025
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
NRY
Catheter, Thrombus Retriever
179d
Cleared
May 15, 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
GXI
Probe, Radiofrequency Lesion
111d
Cleared
May 14, 2025
Helios Dura Regeneration Matrix
GXQ
Dura Substitute
90d
Cleared
May 14, 2025
Nerivio
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
90d
Cleared
May 11, 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
May 09, 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
119d
Cleared
May 09, 2025
PATH BGC
QJP
Catheter, Percutaneous, Neurovasculature
270d
Cleared
May 06, 2025
ANKYRAS
PZO
Software For Visualization Of Vascular Anatomy And Intravascular Devices
105d
Cleared
May 01, 2025
APRO 45 Catheter
DQY
Catheter, Percutaneous
29d
Cleared
Apr 30, 2025
APRO 45 Catheter and Alembic Aspiration Tubing
NRY
Catheter, Thrombus Retriever
28d
Cleared
Apr 29, 2025
APRO 55 Intermediate Catheter
DQY
Catheter, Percutaneous
29d
Cleared
Apr 28, 2025
APRO 55 Swift Catheter and Alembic Aspiration Tubing
NRY
Catheter, Thrombus Retriever
28d
Cleared
Apr 25, 2025
Neu Platform
GYD
Transducer, Tremor
94d
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