510(k) K143609

Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter by Olympus Surgical Technologies America — Product Code FGE

K143609 is an FDA 510(k) premarket notification submitted by Olympus Surgical Technologies America for the device "Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on March 27, 2015. 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 Surgical Technologies America has at least 10 other 510(k) clearances on record.