510(k) K173687

Strange Bile Duct Stone Exploration Set by Cook Incorporated — Product Code LQR

K173687 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Strange Bile Duct Stone Exploration Set". The FDA issued a decision of Substantially Equivalent (kit) on December 15, 2017. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Cook Incorporated has at least 10 other 510(k) clearances on record.