About This 510(k) Submission
K913073 is an FDA 510(k) clearance for the DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on October 25, 1991, 106 days after receiving the submission on July 11, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.