510(k) K140760

BONASTENT BILIARY by Endochoice, Inc. — Product Code FGE

K140760 is an FDA 510(k) premarket notification submitted by Endochoice, Inc. for the device "BONASTENT BILIARY". The FDA issued a decision of SESU on June 16, 2014. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Endochoice, Inc. has at least 10 other 510(k) clearances on record.