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
4696 Neurology devices
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
Cleared
Nov 22, 2021
Spartan MC 0165
QJP
Catheter, Percutaneous, Neurovasculature
27d
Cleared
Nov 18, 2021
DIXI Medical Microdeep Micro-Macro Depth Electrodes
GZL
Electrode, Depth
478d
Cleared
Nov 16, 2021
Esperance Aspiration Catheter System
NRY
Catheter, Thrombus Retriever
166d
Cleared
Nov 16, 2021
InZone Detachment System
HCG
Device, Neurovascular Embolization
103d
Cleared
Nov 12, 2021
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
HAW
Neurological Stereotaxic Instrument
224d
Cleared
Nov 09, 2021
Comby EEG Caps
GXY
Electrode, Cutaneous
193d
Cleared
Nov 08, 2021
GT5 conductive & abrasive gel
GYB
Media, Electroconductive
68d
Cleared
Nov 05, 2021
MStim Drop Model: LGT-233
GZI
Stimulator, Neuromuscular, External Functional
463d
Cleared
Nov 05, 2021
Microcurrent device (Model: HBR2-1)
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
210d
Cleared
Nov 05, 2021
Drug Relief v1
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
134d
Cleared
Nov 03, 2021
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
HAW
Neurological Stereotaxic Instrument
168d
Cleared
Oct 22, 2021
P300 Attachment
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
449d
Cleared
Oct 21, 2021
Legend Pro DMA
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
597d
Cleared
Oct 15, 2021
HIVOX OTC Electrical Stimulator, FT610-B
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
162d
Cleared
Oct 13, 2021
SPRINT PNS System
NHI
Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
125d
Cleared
Oct 13, 2021
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
NRY
Catheter, Thrombus Retriever
30d
Cleared
Oct 08, 2021
B4C System
GWM
Device, Monitoring, Intracranial Pressure
448d
Cleared
Oct 06, 2021
Adhesive Electrodes
GXY
Electrode, Cutaneous
86d
Cleared
Oct 05, 2021
Cala Trio
QBC
External Upper Limb Tremor Stimulator
330d
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