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
4699 Neurology devices
Cleared
Jun 17, 2021
NaviNetics D1 Stereotactic System
HAW
Neurological Stereotaxic Instrument
100d
Cleared
Jun 16, 2021
EnsoSleep
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
161d
Cleared
Jun 11, 2021
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
88d
Cleared
Jun 08, 2021
ZOOM 71 Reperfusion Catheter
NRY
Catheter, Thrombus Retriever
27d
Cleared
Jun 07, 2021
SnugKap
MVA
Orthosis, Cranial
550d
Cleared
Jun 04, 2021
Perfect EMS
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
444d
Cleared
Jun 04, 2021
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
JXL
Block, Bite
385d
Not Cleared
Jun 02, 2021
Cognoa ASD Diagnosis Aid
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
211d
Cleared
Jun 01, 2021
Well-Life Garment Electrodes (GM Series)
GXY
Electrode, Cutaneous
419d
Cleared
May 28, 2021
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
HCG
Device, Neurovascular Embolization
25d
Cleared
May 22, 2021
Neuro-IOM system with Neuro-IOM.NET software
GWF
Stimulator, Electrical, Evoked Response
796d
Cleared
May 20, 2021
Quick-20m
GWL
Amplifier, Physiological Signal
189d
Cleared
May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
NRY
Catheter, Thrombus Retriever
178d
Cleared
May 04, 2021
Rebellion, Phantom Multi-Bite Kerrison Rongeur
HAE
Rongeur, Manual
405d
Cleared
Apr 30, 2021
CereLink ICP Monitor
GWM
Device, Monitoring, Intracranial Pressure
28d
Cleared
Apr 28, 2021
Plato 17 Microcatheter
DQY
Catheter, Percutaneous
58d
Cleared
Apr 27, 2021
Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
645d
Cleared
Apr 27, 2021
STARband, STARlight, St. Louis Band
OAN
Orthosis, Cranial, Laser Scan
195d
Cleared
Apr 23, 2021
Brainsway Deep TMS System
OBP
Transcranial Magnetic Stimulator
123d
Cleared
Apr 23, 2021
ZOOM (71, 55, 45, 35) Reperfusion Catheters
NRY
Catheter, Thrombus Retriever
21d
Cleared
Apr 20, 2021
Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)
NOY
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
165d
Cleared
Apr 16, 2021
Brainsway Deep (DTMS) System
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
127d
Cleared
Apr 11, 2021
Velocity Alpha Highspeed Surgical Drill System
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
677d
Cleared
Apr 09, 2021
hekaDrill
HBC
Motor, Drill, Electric
470d
Cleared
Apr 02, 2021
ClearPath Disposable Introducer
GWG
Endoscope, Neurological
63d
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