510(k) K894871

WILTEK BILIARY STENT SET by Wiltek Medical, Inc. — Product Code FGE

K894871 is an FDA 510(k) premarket notification submitted by Wiltek Medical, Inc. for the device "WILTEK BILIARY STENT SET". The FDA issued a decision of Substantially Equivalent on December 21, 1989. 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. Wiltek Medical, Inc. has at least 10 other 510(k) clearances on record.