510(k) K170740

GORE VIABIL Short Wire Biliary Endoprosthesis by W. L. Gore & Associates, Inc. — Product Code FGE

K170740 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE VIABIL Short Wire Biliary Endoprosthesis". The FDA issued a decision of Substantially Equivalent - With Limitations on May 8, 2017. 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. W. L. Gore & Associates, Inc. has 165 other 510(k) clearances on record.