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
6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
Cleared
Dec 21, 2022
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Dec 20, 2022
Penumbra System (Reperfusion Catheter RED 43)
NRY
Catheter, Thrombus Retriever
95d
Cleared
Dec 14, 2022
Target Tetra Detachable Coils
HCG
Device, Neurovascular Embolization
114d
Cleared
Dec 13, 2022
Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
529d
Cleared
Dec 13, 2022
Conductive Gel
GYB
Media, Electroconductive
90d
Cleared
Dec 09, 2022
CELLO II Balloon Guide Catheter
QJP
Catheter, Percutaneous, Neurovasculature
46d
Cleared
Dec 08, 2022
IRRAflow Active Fluid Exchange System (AFES)
JXG
Shunt, Central Nervous System And Components
114d
Cleared
Dec 06, 2022
iCE-SG2 Subcutaneous Electrode Kit
GZL
Electrode, Depth
90d
Cleared
Dec 06, 2022
Optima Coil System
HCG
Device, Neurovascular Embolization
29d
Cleared
Nov 30, 2022
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
OLT
Non-normalizing Quantitative Electroencephalograph Software
303d
Cleared
Nov 28, 2022
pNOVUS 21 Microcatheter
DQO
Catheter, Intravascular, Diagnostic
209d
Cleared
Nov 22, 2022
WISE Cortical Strip (WCS)
GYC
Electrode, Cortical
218d
Cleared
Nov 22, 2022
Cala kIQ
QBC
External Upper Limb Tremor Stimulator
119d
Cleared
Nov 17, 2022
Parky App
GYD
Transducer, Tremor
241d
Cleared
Nov 15, 2022
Everyway Analog OTC TENS
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Nov 15, 2022
2.1 x 255mm Drill, 22mm Stop
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
33d
Cleared
Nov 11, 2022
Mapping Suction Probe
ETN
Stimulator, Nerve
487d
Cleared
Nov 10, 2022
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
GYC
Electrode, Cortical
505d
Cleared
Nov 04, 2022
BENCHMARK BMX81 Access System
QJP
Catheter, Percutaneous, Neurovasculature
134d
Cleared
Nov 04, 2022
Self-adhesive Electrode
GXY
Electrode, Cutaneous
81d
Cleared
Nov 04, 2022
Aquilo Sports CCT1500 System
IRP
Massager, Powered Inflatable Tube
28d
Cleared
Oct 31, 2022
ORiGO System
HBC
Motor, Drill, Electric
342d
Cleared
Oct 28, 2022
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
GXN
Plate, Cranioplasty, Preformed, Non-alterable
303d
Cleared
Oct 26, 2022
Intracept Intraosseous Nerve Ablation System
GXI
Probe, Radiofrequency Lesion
89d
Cleared
Oct 24, 2022
Neurosteer EEG Recorder
OMC
Reduced- Montage Standard Electroencephalograph
146d
Looking for a specific neurology device? Search by device name, K-number or manufacturer.
Search all Neurology 510(k) devices