FDA.reportPublic FDA data

De Novo DEN220073

Device
Revi System
Contact
roni diaz
De Novo number
DEN220073
Product code
QXM
Regulation
876.5305
Classification name
implanted tibial electrical urinary continence device
Decision
granted (DENG)
Decision date
2023-08-16
Date received
2022-10-05
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Direct

Current FDA Classification#

Product code
QXM
Device name
Implanted Tibial Electrical Urinary Continence Device
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.5305
Implant
Y
Life sustain/support
N