FDA.reportPublic FDA data

De Novo DEN230032

Device
Symani Surgical System
Contact
mauro ercolani
De Novo number
DEN230032
Product code
SAQ
Regulation
878.4963
Classification name
electromechanical system for open microsurgery
Decision
granted (DENG)
Decision date
2024-04-05
Date received
2023-04-25
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
SAQ
Device name
Electromechanical System For Open Microsurgery
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4963
Implant
N
Life sustain/support
N