510(k) Report

Devices descending from K010242

33 later devices reach Cook Zilver Biliary Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081956Medinol X-Suit Nir Biliary Metallic StentMedinol, Ltd.20090—
+1K020788Wilson-Cook Zilver Biliary StentWilson-Cook Medical, Inc.2002323
+2K163018Zilver 635 Biliary StentCook Ireland, Ltd.20163—
+2K072720Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc.200816
+2K040930Zilver Biliary Stent System UswWilson-Cook Medical, Inc.200424—
+3K171809Epic Biliary Endoscopic Stent SystemBoston Scientific Corporation20172—
+3K093947Alimaxx-B Uncovered Biliary Stent System EndoscopicMerit Medical Systems, Inc.20100—
+3K073667Niti-S Biliary StentTaewoong Medical Co., Ltd.200823—
+4K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20250—
+4K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific20241—
+4K223626Niti-S Biliary Speed D StentTaewoong Medical Co., Ltd.20230—
+4K221071Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20221—
+4K113551Esophageal TTS StentTaewoong Medical Co., Ltd.2012101
+4K111149Hanarostent Biliary (NNN)M.I.Tech Co., Ltd.20116—
+4K093003Bonastent BiliaryEndochoice, Inc.20103—
+5K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific20240—
+5K223354EGIS Biliary Single Bare StentS&G Biotech, Inc.20231—
+5K221482Esophageal TTS StentTaewoong Medical Co., Ltd.20222—
+5K211706Esophageal TTS StentTaewoong Medical Co., Ltd.20213—
+5K202973HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd.20212—
+5K183396HANAROSTENT FASTTM Biliary (NNN)M.I.Tech Co., Ltd.20190—
+5K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+5K140760Bonastent BiliaryEndochoice, Inc.20140—
+5K123205Esophageal TTS StentTaewoong Medical Co., Ltd.201391
+6K242845EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc.20250—
+6K240522Esophageal TTS StentTaewoong Medical20241—
+6K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+6K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.20200—
+6K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+7K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.20250—
+7K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+7K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+8K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—