510(k) K914881

WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER by Wiltek Medical, Inc. — Product Code FGE

K914881 is an FDA 510(k) premarket notification submitted by Wiltek Medical, Inc. for the device "WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER". The FDA issued a decision of Substantially Equivalent on January 7, 1992. 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.