510(k) K211960

Agile Esophageal OTW Stent System by Boston Scientific Corporation — Product Code ESW

K211960 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Agile Esophageal OTW Stent System". The FDA issued a decision of Substantially Equivalent on November 22, 2021. 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.