510(k) K152069

Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter by Navilyst Medical, Inc. — Product Code FGE

K152069 is an FDA 510(k) premarket notification submitted by Navilyst Medical, Inc. for the device "Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter". The FDA issued a decision of Substantially Equivalent on September 24, 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. Navilyst Medical, Inc. has at least 10 other 510(k) clearances on record.