Product code QXH

Device name

Gallbladder Drainage Stent And Delivery System

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5016

Review panel

GU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset