510(k) K933200

OLYMPUS PBD STENTS by Olympus Corp. — Product Code FGE

K933200 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "OLYMPUS PBD STENTS". The FDA issued a decision of Substantially Equivalent on April 5, 1995. 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. Olympus Corp. has at least 10 other 510(k) clearances on record.