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, Micro-Tech (Nanjing) Co., Ltd. and Olympus Medical Systems Corp..
List of Dislodger, Stone, Biliary devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Dislodger, Stone, Biliary devices (product code LQR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →