510(k) K821819

PIGTAIL STENTS by American Endoscopy, Inc. — Product Code FGE

K821819 is an FDA 510(k) premarket notification submitted by American Endoscopy, Inc. for the device "PIGTAIL STENTS". The FDA issued a decision of Substantially Equivalent on August 20, 1982. 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. American Endoscopy, Inc. has at least 10 other 510(k) clearances on record.