510(k) Report

Devices descending from K012752

37 later devices reach Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121430Evolution Biliary Stent SystemCook Ireland, Ltd.20130—
+1K083374Wallflex Biliary RX Partially-Covered Stent SystemBoston Scientific Corp20096—
+1K083627Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520…Boston Scientific Corporation20096—
+1K081956Medinol X-Suit Nir Biliary Metallic StentMedinol, Ltd.20090—
+1K073667Niti-S Biliary StentTaewoong Medical Co., Ltd.200823—
+1K061231Wellflex Biliary RX Stent SystemBoston Scientific Corp200610—
+1K030107100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMBoston Scientific Corp2003111
+2K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20250—
+2K223626Niti-S Biliary Speed D StentTaewoong Medical Co., Ltd.20230—
+2K221071Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20221—
+2K122072Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered)…Boston Scientific Corporation20124—
+2K113551Esophageal TTS StentTaewoong Medical Co., Ltd.2012101
+2K111149Hanarostent Biliary (NNN)M.I.Tech Co., Ltd.20116—
+2K112543Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic…Boston Scientific Corporation20115—
+2K093003Bonastent BiliaryEndochoice, Inc.20103—
+2K08173310MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890Boston Scientific Corp20087—
+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—
+3K183396HANAROSTENT FASTTM Biliary (NNN)M.I.Tech Co., Ltd.20190—
+3K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+3K140760Bonastent BiliaryEndochoice, Inc.20140—
+3K140630Wallflex Biliary RX Stent SystemBoston Scientific201431
+3K123205Esophageal TTS StentTaewoong Medical Co., Ltd.201391
+4K242845EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc.20250—
+4K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific20241—
+4K240522Esophageal TTS StentTaewoong Medical20241—
+4K223469WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation20231—
+4K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+4K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.20200—
+4K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+5K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.20250—
+5K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific20240—
+5K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+5K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+6K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—