510(k) Report

Devices descending from K000281

31 later devices reach Wallstent Enternal Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113510Evolution Colonic Stent SystemCook Ireland, Ltd.20123—
+1K062750Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010…Boston Scientific Corp200611—
+1K061877Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemBoston Scientific Corp200610—
+1K060323Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380Boston Scientific Corporation2006111
+1K042065Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp2004291
+2K201159WallFlex Colonic Stent System with Anchor Lock Delivery SystemBoston Scientific Corporation20201—
+2K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…Boston Scientific Corporation20201—
+2K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.20184—
+2K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredCook Ireland, Ltd.20172—
+2K101530Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-DCook Ireland, Ltd.20114—
+2K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp200815—
+3K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…Boston Scientific Corporation20240—
+3K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+3K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.20193—
+3K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+3K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+3K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation200914—
+4K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+4K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+4K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.20231—
+4K190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd.20192—
+4K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20183—
+4K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+4K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+5K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—
+5K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.20250—
+5K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+5K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.20212—
+5K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+6K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.20250—
+6K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.20210—