510(k) Report

Devices descending from K990034

20 later devices reach Wilson-Cook Colonic Z-Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011591Esophageal Z-Stent with Dua Anti-Reflux ValveWilson-Cook Medical, Inc.200219—
+2K080782Niti-S Esophageal StentTaewoong Medical Co., Ltd.2009151
+2K080359Evolution Esophageal Stent SystemCook Ireland, Ltd.20082—
+3K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.20250—
+3K223266Hilzo Esophageal StentsThoracent, Inc.20240—
+3K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd.20160—
+3K123205Esophageal TTS StentTaewoong Medical Co., Ltd.201391
+3K113551Esophageal TTS StentTaewoong Medical Co., Ltd.2012101
+3K093619Evolution Esophageal Stent Fully Covered, Models Evo-FC-18-23-8-E, Evo-FC-18-23-10-E…Cook Ireland, Ltd.20101—
+3K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+4K221482Esophageal TTS StentTaewoong Medical Co., Ltd.20222—
+4K211706Esophageal TTS StentTaewoong Medical Co., Ltd.20213—
+4K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.20200—
+4K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+4K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+5K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+5K240522Esophageal TTS StentTaewoong Medical20241—
+5K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+5K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+6K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—