510(k) K913986

CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM by Medical Dynamics, Inc. — Product Code FGE

K913986 is an FDA 510(k) premarket notification submitted by Medical Dynamics, Inc. for the device "CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM". The FDA issued a decision of Substantially Equivalent (kit) on January 28, 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. Medical Dynamics, Inc. has at least 10 other 510(k) clearances on record.