510(k) Report

Devices descending from K010068

16 later devices reach Rusch Polyflex Stent for the Esophagus with Introducer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp200815—
+2K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+2K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+2K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+2K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation200914—
+3K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+3K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+3K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20183—
+3K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+3K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+4K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—
+4K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+4K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.20212—
+4K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+5K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.20250—
+5K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.20210—