About This 510(k) Submission
K023217 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. (Miami Lakes, US). The FDA issued a Cleared decision on October 25, 2002, 29 days after receiving the submission on September 26, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.