510(k) K191789

Stonetome Stone Removal Device by Boston Scientific Corporation — Product Code LQR

K191789 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Stonetome Stone Removal Device". The FDA issued a decision of Substantially Equivalent (kit) on July 25, 2019. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.