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
554 Neurology devices
Cleared
Nov 22, 2024
Cala kIQ
QBC
External Upper Limb Tremor Stimulator
114d
Cleared
Nov 22, 2024
Nooro Body & Foot Stimulator (SM9141, SM9142)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
29d
Cleared
Nov 20, 2024
Neurovascular Access System Family
QJP
Catheter, Percutaneous, Neurovasculature
246d
Cleared
Nov 19, 2024
Natus BrainWatch System
OMC
Reduced- Montage Standard Electroencephalograph
56d
Cleared
Nov 18, 2024
Synxess Neurovascular Guidewire
MOF
Guide, Wire, Catheter, Neurovasculature
234d
Not Cleared
Nov 13, 2024
SmartFlow Neuro Cannula
SDG
Brain Intraparenchymal Infusion Cannula
175d
Cleared
Nov 12, 2024
pNOVUS 21 Microcatheter
DQO
Catheter, Intravascular, Diagnostic
89d
Cleared
Nov 06, 2024
ELEXIR 2.0 (ALLIVE3)
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
57d
Cleared
Nov 05, 2024
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Nov 05, 2024
Delphi Stimulator
GWF
Stimulator, Electrical, Evoked Response
90d
Cleared
Oct 29, 2024
Riptide Aspiration System
NRY
Catheter, Thrombus Retriever
29d
Cleared
Oct 29, 2024
AtriCure cryoICE BOX (ACM)
GXH
Device, Surgical, Cryogenic
29d
Cleared
Oct 24, 2024
Duet External Drainage and Monitoring System (EDMS)
PCB
External Cerebrospinal Fluid (csf) Diversion
105d
Cleared
Oct 18, 2024
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
389d
Cleared
Oct 17, 2024
REMI-AI Rapid Detection Module (REMI-AI RDM)
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
251d
Cleared
Oct 17, 2024
Zipline Access Catheter
QJP
Catheter, Percutaneous, Neurovasculature
216d
Cleared
Oct 16, 2024
Cerebral Autoregulation Index (CAI) Algorithm
MUD
Oximeter, Tissue Saturation
226d
Cleared
Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
NRY
Catheter, Thrombus Retriever
168d
Cleared
Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
QJP
Catheter, Percutaneous, Neurovasculature
167d
Cleared
Oct 11, 2024
QUEX ED
OMC
Reduced- Montage Standard Electroencephalograph
396d
Cleared
Oct 08, 2024
Nerivio
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
112d
Cleared
Oct 04, 2024
Zeta Cranial Navigation System (ZNS131-US)
HAW
Neurological Stereotaxic Instrument
57d
Cleared
Oct 02, 2024
8F Modified Sheath System
QJP
Catheter, Percutaneous, Neurovasculature
222d
Cleared
Oct 01, 2024
Esperance 3+ Aspiration Catheter System
NRY
Catheter, Thrombus Retriever
181d
Cleared
Sep 30, 2024
Numen™ Coil Embolization System
HCG
Device, Neurovascular Embolization
69d
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