De Novo DEN220082

Device
Breast Implant Removal Device (BIRD)
Contact
alex cerveniak
De Novo number
DEN220082
Product code
QVS
Regulation
878.4675
Classification name
breast implant suction retrieval device
Decision
granted (DENG)
Decision date
2023-04-20
Date received
2022-11-21
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
QVS
Device name
Breast Implant Suction Retrieval Device
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4675
Implant
N
Life sustain/support
N