About This 510(k) Submission
K152069 is an FDA 510(k) clearance for the Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on September 24, 2015, 59 days after receiving the submission on July 27, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.