FDA.reportPublic FDA data

De Novo DEN150022

Device
Ultravision Visual Clearing System
Contact
dominic griffiths
De Novo number
DEN150022
Product code
PQM
Regulation
878.5050
Classification name
surgical smoke precipitator
Decision
granted (DENG)
Decision date
2016-12-20
Date received
2015-05-26
Classification advisory
General & Plastic Surgery
Review advisory
General Hospital
Type
Direct

Current FDA Classification#

Product code
PQM
Device name
Surgical Smoke Precipitator
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.5050
Implant
N
Life sustain/support
N