PJH · Class II · 21 CFR 876.5930

FDA Product Code PJH: Dynamic Rectal Control System

Intended To Treat Fecal Incontinence By Controlling The Size Of The Rectal Lumen.

Leading manufacturers include Pelvalon and Pelvalon, Inc..

2
Total
1
Cleared
243d
Avg days
2015
Since

FDA 510(k) Cleared Dynamic Rectal Control System Devices (Product Code PJH)

2 devices
1–2 of 2
Cleared Nov 12, 2015
Eclipse System
K150558
Pelvalon, Inc.
Gastroenterology & Urology · 253d
Not Cleared Feb 12, 2015
ECLIPSE SYSTEM
DEN140020
Pelvalon
Gastroenterology & Urology · 233d

About Product Code PJH - Regulatory Context