510(k) Report

Devices descending from K080782

15 later devices reach Niti-S Esophageal Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.20250—
+1K223266Hilzo Esophageal StentsThoracent, Inc.20240—
+1K123205Esophageal TTS StentTaewoong Medical Co., Ltd.201391
+1K113551Esophageal TTS StentTaewoong Medical Co., Ltd.2012101
+1K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+2K221482Esophageal TTS StentTaewoong Medical Co., Ltd.20222—
+2K211706Esophageal TTS StentTaewoong Medical Co., Ltd.20213—
+2K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.20200—
+2K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+2K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+3K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+3K240522Esophageal TTS StentTaewoong Medical20241—
+3K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+3K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+4K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—