510(k) Report

Devices descending from K011591

19 later devices reach Esophageal Z-Stent with Dua Anti-Reflux Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080782Niti-S Esophageal StentTaewoong Medical Co., Ltd.2009151
+1K080359Evolution Esophageal Stent SystemCook Ireland, Ltd.20082—
+2K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.20250—
+2K223266Hilzo Esophageal StentsThoracent, Inc.20240—
+2K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd.20160—
+2K123205Esophageal TTS StentTaewoong Medical Co., Ltd.201391
+2K113551Esophageal TTS StentTaewoong Medical Co., Ltd.2012101
+2K093619Evolution Esophageal Stent Fully Covered, Models Evo-FC-18-23-8-E, Evo-FC-18-23-10-E…Cook Ireland, Ltd.20101—
+2K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+3K221482Esophageal TTS StentTaewoong Medical Co., Ltd.20222—
+3K211706Esophageal TTS StentTaewoong Medical Co., Ltd.20213—
+3K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.20200—
+3K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+3K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+4K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+4K240522Esophageal TTS StentTaewoong Medical20241—
+4K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+4K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+5K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—