FDA.reportPublic FDA data

De Novo DEN230084

Device
Dexter L6 System
Contact
larry carrier
De Novo number
DEN230084
Product code
SDD
Regulation
878.4965
Classification name
electromechanical surgical system wherein the surgeon annd the user interface can be in the sterile field
Decision
granted (DENG)
Decision date
2024-10-25
Date received
2023-12-15
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
SDD
Device name
Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4965
Implant
N
Life sustain/support
N