510(k) Report

Devices descending from K073667

23 later devices reach Niti-S Biliary Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20250—
+1K223626Niti-S Biliary Speed D StentTaewoong Medical Co., Ltd.20230—
+1K221071Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20221—
+1K113551Esophageal TTS StentTaewoong Medical Co., Ltd.2012101
+1K111149Hanarostent Biliary (NNN)M.I.Tech Co., Ltd.20116—
+1K093003Bonastent BiliaryEndochoice, Inc.20103—
+2K223354EGIS Biliary Single Bare StentS&G Biotech, Inc.20231—
+2K221482Esophageal TTS StentTaewoong Medical Co., Ltd.20222—
+2K211706Esophageal TTS StentTaewoong Medical Co., Ltd.20213—
+2K202973HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd.20212—
+2K183396HANAROSTENT FASTTM Biliary (NNN)M.I.Tech Co., Ltd.20190—
+2K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+2K140760Bonastent BiliaryEndochoice, Inc.20140—
+2K123205Esophageal TTS StentTaewoong Medical Co., Ltd.201391
+3K242845EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc.20250—
+3K240522Esophageal TTS StentTaewoong Medical20241—
+3K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+3K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.20200—
+3K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+4K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.20250—
+4K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+4K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+5K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—