510(k) K180086

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter by Gyrus Acmi, Inc. — Product Code FGE

K180086 is an FDA 510(k) premarket notification submitted by Gyrus Acmi, Inc. for the device "Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on March 8, 2018. 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. Gyrus Acmi, Inc. has at least 10 other 510(k) clearances on record.