FDA.reportPublic FDA data

De Novo DEN130044

Device
INFLOW INTRAURETHRAL VALVE-PUMP
Contact
kevin m connolly
De Novo number
DEN130044
Product code
PIH
Regulation
876.5140
Classification name
urethral insert with pump for bladder drainage
Decision
granted (DENG)
Decision date
2014-10-14
Date received
2013-10-25
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Direct

Current FDA Classification#

Product code
PIH
Device name
Urethral Insert With Pump For Bladder Drainage
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.5140
Implant
Y
Life sustain/support
N