QXH

Gallbladder Drainage Stent And Delivery System

Product code

QXH

Device name

Gallbladder Drainage Stent And Delivery System

Device class

Class 2

21 CFR

21 CFR 876.5016

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 gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system.

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