510(k) Report

Devices descending from K080838

17 later devices reach Alveolus Alimaxx-E Esophageal Stent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+1K111611Endomaxx Fully Covered Esophageal StentMerit Medical Systems, Inc.20111—
+1K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation200914—
+2K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.20250—
+2K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+2K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+2K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+2K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20183—
+2K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+2K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+3K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—
+3K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+3K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.20212—
+3K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+4K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.20250—
+4K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.20210—
+4K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—