FDA.reportPublic FDA data

De Novo DEN140020

Device
ECLIPSE SYSTEM
Contact
cindy domecus
De Novo number
DEN140020
Product code
PJH
Regulation
876.5930
Classification name
dynamic rectal control system
Decision
granted (DENG)
Decision date
2015-02-12
Date received
2014-06-24
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Direct

Current FDA Classification#

Product code
PJH
Device name
Dynamic Rectal Control System
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.5930
Implant
N
Life sustain/support
N