510(k) K261978

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System by Boston Scientific Corporation — Product Code ESW

K261978 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System". The FDA issued a decision of Substantially Equivalent on July 10, 2026. 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.