510(k) Report

Devices descending from K041648

27 later devices reach Niti-S Stent & Introducer, Model Eoxxxx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+1K080782Niti-S Esophageal StentTaewoong Medical Co., Ltd.2009151
+1K073667Niti-S Biliary StentTaewoong Medical Co., Ltd.200823—
+2K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20250—
+2K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.20250—
+2K223266Hilzo Esophageal StentsThoracent, Inc.20240—
+2K223626Niti-S Biliary Speed D StentTaewoong Medical Co., Ltd.20230—
+2K221071Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20221—
+2K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+2K123205Esophageal TTS StentTaewoong Medical Co., Ltd.201391
+2K113551Esophageal TTS StentTaewoong Medical Co., Ltd.2012101
+2K111149Hanarostent Biliary (NNN)M.I.Tech Co., Ltd.20116—
+2K093003Bonastent BiliaryEndochoice, Inc.20103—
+3K223354EGIS Biliary Single Bare StentS&G Biotech, Inc.20231—
+3K221482Esophageal TTS StentTaewoong Medical Co., Ltd.20222—
+3K211706Esophageal TTS StentTaewoong Medical Co., Ltd.20213—
+3K202973HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd.20212—
+3K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+3K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.20200—
+3K183396HANAROSTENT FASTTM Biliary (NNN)M.I.Tech Co., Ltd.20190—
+3K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+3K140760Bonastent BiliaryEndochoice, Inc.20140—
+4K242845EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc.20250—
+4K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+4K240522Esophageal TTS StentTaewoong Medical20241—
+4K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+5K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—