510(k) Report

Devices descending from K123205

9 later devices reach Esophageal TTS Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221482Esophageal TTS StentTaewoong Medical Co., Ltd.20222—
+1K211706Esophageal TTS StentTaewoong Medical Co., Ltd.20213—
+1K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.20200—
+1K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+2K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+2K240522Esophageal TTS StentTaewoong Medical20241—
+2K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+3K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—
+3K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.20250—