FDA Product Code LQR: Dislodger, Stone, Biliary

FDA product code LQR covers biliary stone dislodgers used endoscopically or percutaneously to break up and remove calculi from the bile ducts.

These basket, balloon, or mechanical lithotripsy devices are used to capture, fragment, and extract stones from the common bile duct during ERCP procedures, avoiding the need for surgical common bile duct exploration.

LQR devices are Class II medical devices, regulated under 21 CFR 876.5010 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Boston Scientific Corporation, Jiangsu Vedkang Medical Science and Technology Co., Ltd. and Scivita Medical Technology Co., Ltd..