About This 510(k) Submission
K042969 is an FDA 510(k) clearance for the MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY 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 November 8, 2004, 11 days after receiving the submission on October 28, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.