510(k) Report

Devices descending from K130004

2 later devices reach Ultraflex Esophageal NG Stent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+2K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—