510(k) K892384

BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER by Porges Corp. — Product Code FGE

K892384 is an FDA 510(k) premarket notification submitted by Porges Corp. for the device "BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER". The FDA issued a decision of Substantially Equivalent on May 4, 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. Porges Corp. has at least 10 other 510(k) clearances on record.