FDA.reportPublic FDA data

De Novo DEN190022

Device
Hominis Surgical System
Contact
maya leib shlomo
De Novo number
DEN190022
Product code
QNM
Regulation
878.4961
Classification name
mountable electromechanical surgical system for transluminal approaches
Decision
granted (DENG)
Decision date
2021-02-26
Date received
2019-04-17
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
QNM
Device name
Mountable Electromechanical Surgical System For Transluminal Approaches
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4961
Implant
N
Life sustain/support
N