PJH

Dynamic Rectal Control System

Product code: PJH
Device name: Dynamic Rectal Control System
Device class: Class 2
21 CFR: 21 CFR 876.5930
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 2 (all years; only the last 3 years are listed here)

FDA classification definition

Intended to treat fecal incontinence by controlling the size of the rectal lumen.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PJH

Classification and pathway per current FDA publications. Data from openFDA (CC0).