510(k) K113582

ARCHSTENT BILIARY SYSTEM by Ostial Corporation — Product Code FGE

K113582 is an FDA 510(k) premarket notification submitted by Ostial Corporation for the device "ARCHSTENT BILIARY SYSTEM". The FDA issued a decision of SESU on June 29, 2012. 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. Ostial Corporation has at least 10 other 510(k) clearances on record.