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
6235
Total
6180
Cleared
154d
Avg (2y)
1976
Since
1712 Neurology devices
Cleared
Dec 30, 2021
Intrelief
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
248d
Cleared
Dec 29, 2021
CONVIVO In Vivo Pathology Suite
LLZ
System, Image Processing, Radiological
254d
Cleared
Dec 23, 2021
Twist Drills
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
85d
Cleared
Dec 22, 2021
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
154d
Cleared
Dec 22, 2021
EyeBOX (Model EBX-4)
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
152d
Cleared
Dec 22, 2021
StealthStation S8 Cranial v2.0
HAW
Neurological Stereotaxic Instrument
142d
Cleared
Dec 21, 2021
Meticuly Patient-Specific Titanium Mesh Implant
GXN
Plate, Cranioplasty, Preformed, Non-alterable
341d
Cleared
Dec 20, 2021
First Relief
NHI
Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
103d
Cleared
Dec 20, 2021
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
NCX
System, Hypothermia, Intravenous, Cooling
90d
Cleared
Dec 17, 2021
EMBOGUARD Balloon Guide Catheter
QJP
Catheter, Percutaneous, Neurovasculature
142d
Cleared
Dec 16, 2021
MIVI Q Distal Access Catheter
QJP
Catheter, Percutaneous, Neurovasculature
136d
Cleared
Dec 15, 2021
Transcutaneous Electrical Nerve Stimulator
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
321d
Cleared
Dec 13, 2021
Aesculap Slim Clip Applier
HCI
Applier, Aneurysm Clip
206d
Cleared
Dec 13, 2021
Heat StimPlus
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Dec 10, 2021
Branchor Balloon Guide Catheter
QJP
Catheter, Percutaneous, Neurovasculature
354d
Cleared
Dec 10, 2021
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
OBP
Transcranial Magnetic Stimulator
32d
Cleared
Dec 05, 2021
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
MUD
Oximeter, Tissue Saturation
199d
Cleared
Dec 03, 2021
Molecular Flow Simulations
HAW
Neurological Stereotaxic Instrument
550d
Cleared
Dec 02, 2021
AURORA Evacuator +Coag
GEI
Electrosurgical, Cutting & Coagulation & Accessories
345d
Cleared
Dec 02, 2021
Encevis
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
206d
Cleared
Dec 01, 2021
AC Cream - Conductive paste
GYB
Media, Electroconductive
128d
Cleared
Nov 26, 2021
ALTMS Magnetic Stimulation Therapy System
OBP
Transcranial Magnetic Stimulator
451d
Cleared
Nov 26, 2021
Trevo Trak 21 Microcatheter
QJP
Catheter, Percutaneous, Neurovasculature
186d
Cleared
Nov 23, 2021
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
28d
Cleared
Nov 22, 2021
Low-frequency Stimulator (Model: AST-645, AST-646)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
63d
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