Product code PJH

Device name
Dynamic Rectal Control System
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5930
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Intended to treat fecal incontinence by controlling the size of the rectal lumen.
Source
FDA openFDA device classification dataset