Product code PNB

Device name

Biliary Stent System For Benign Strictures

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5011

Review panel

GU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset