FDA.reportPublic FDA data

De Novo DEN230078

Device
Versius Surgical System
Contact
chris weatherall
De Novo number
DEN230078
Product code
SCV
Regulation
878.4964
Classification name
modular electromechanical surgical system
Decision
granted (DENG)
Decision date
2024-10-11
Date received
2023-11-21
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
SCV
Device name
Modular Electromechanical Surgical System
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4964
Implant
N
Life sustain/support
N