510(k) K130004

ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM by Boston Scientific Corporation — Product Code ESW

K130004 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 6, 2013. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.