510(k) Report

Devices descending from K180144

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+1K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+2K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—