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, Scivita Medical Technology Co., Ltd. and Micro-Tech (Nanjing) Co., Ltd..
FDA 510(k) Cleared Dislodger, Stone, Biliary Devices (Product Code LQR)
About Product Code LQR - Regulatory Context
510(k) Submission Activity
38 total 510(k) submissions under product code LQR since 1985, with 38 receiving FDA clearance (average review time: 123 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LQR have taken an average of 148 days to reach a decision - up from 120 days historically. Manufacturers should account for longer review timelines in current project planning.
LQR devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →