510(k) Report

Devices descending from K211960

2 later devices reach Agile Esophageal OTW Stent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+2K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—