About This 510(k) Submission
K033394 is an FDA 510(k) clearance for the CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on December 22, 2003, 60 days after receiving the submission on October 23, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.