PNB

Biliary Stent System For Benign Strictures

Product code

PNB

Device name

Biliary Stent System For Benign Strictures

Device class

Class 2

21 CFR

21 CFR 876.5011

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

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

FDA classification definition

A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metal stent and a delivery system intended to place the stent in the biliary ducts.

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