510(k) Report

Devices descending from K091510

14 later devices reach Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+1K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+1K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+1K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20183—
+1K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+1K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+2K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—
+2K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+2K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+2K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.20212—
+2K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+3K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.20250—
+3K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.20210—
+3K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—