510(k) Report

Devices descending from K091816

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation20132—
+1K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp20125—
+1K120983Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation20123—
+2K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+2K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+2K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+3K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—