510(k) K943143

BILIARY STENT by Menlo Care, Inc. — Product Code FGE

K943143 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "BILIARY STENT". The FDA issued a decision of Substantially Equivalent on February 28, 1995. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Menlo Care, Inc. has at least 10 other 510(k) clearances on record.