QUN

Tether Accessory For Use In The Gastrointestinal Tract

Product code

QUN

Device name

Tether Accessory For Use In The Gastrointestinal Tract

Device class

Class 2

21 CFR

21 CFR 876.1305

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

FDA classification definition

A non-powered, detachable, flexible tether accessory used to maneuver a swallowed device, such as a capsule, in the upper gastrointestinal tract.

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