FDA.reportPublic FDA data

De Novo DEN130023

Device
UROLIFT SYSTEM
Contact
nancy e isaac
De Novo number
DEN130023
Product code
PEW
Regulation
876.5530
Classification name
implantable transprostatic tissue retractor system
Decision
granted (DENG)
Decision date
2013-09-13
Date received
2013-03-07
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Direct

Current FDA Classification#

Product code
PEW
Device name
Implantable Transprostatic Tissue Retractor System
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.5530
Implant
Y
Life sustain/support
N