PBP

Rectal Insert

Product code

PBP

Device name

Rectal Insert

Device class

Class 2

21 CFR

21 CFR 876.5980

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

Acts as a barrier to the passage of fecal matter through the rectum.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-07-22.

1 summaries are archived here for direct download.