About This 510(k) Submission
K152853 is an FDA 510(k) clearance for the WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on November 20, 2015, 52 days after receiving the submission on September 29, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.