510(k) Report

Devices descending from K961262

55 later devices reach Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081956Medinol X-Suit Nir Biliary Metallic StentMedinol, Ltd.20090—
+1K012752Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp2001371
+1K982005Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc.19980—
+1K982184Wallstent EndoprosthesisBoston Scientific Scimed, Inc.199840—
+1K980653Perflex Stainless Steel Stent and Delivery SystemCordis Corp.19987—
+1K964119Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc.1997546
+2K121430Evolution Biliary Stent SystemCook Ireland, Ltd.20130—
+2K112543Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic…Boston Scientific Corporation20115—
+2K083374Wallflex Biliary RX Partially-Covered Stent SystemBoston Scientific Corp20096—
+2K083627Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520…Boston Scientific Corporation20096—
+2K073667Niti-S Biliary StentTaewoong Medical Co., Ltd.200823—
+2K061231Wellflex Biliary RX Stent SystemBoston Scientific Corp200610—
+2K030107100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMBoston Scientific Corp2003111
+2K993232Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemBoston Scientific Scimed, Inc.199914—
+2K992816Modification to IntrastentIntratherapeutics, Inc.19990—
+2K992319RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemGuidant Corp.19992—
+2K991929IntrastentIntratherapeutics, Inc.19993—
+2K990221Intracoil Peripheral StentIntratherapeutics, Inc.19991—
+3K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20250—
+3K223626Niti-S Biliary Speed D StentTaewoong Medical Co., Ltd.20230—
+3K221071Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20221—
+3K152853WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic…Boston Scientific Corp20150—
+3K122072Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered)…Boston Scientific Corporation20124—
+3K113551Esophageal TTS StentTaewoong Medical Co., Ltd.2012101
+3K111149Hanarostent Biliary (NNN)M.I.Tech Co., Ltd.20116—
+3K093003Bonastent BiliaryEndochoice, Inc.20103—
+3K08173310MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890Boston Scientific Corp20087—
+3K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc.20060—
+3K053459Omnilink .035 Biliary Stent SystemGuidant Corporation20060—
+3K021563Intracoil Self-Expanding Peripheral StentSulzer Intratherapeutics, Inc.20020—
+3K020528Intrastent LD (Large Diameter) StentSulzer Intratherapeutics, Inc.20020—
+3K012822Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model…Boston Scientific Scimed, Inc.20011—
+3K993904Intrastent Doublestrut LDIntratherapeutics, Inc.200011
+4K223354EGIS Biliary Single Bare StentS&G Biotech, Inc.20231—
+4K221482Esophageal TTS StentTaewoong Medical Co., Ltd.20222—
+4K211706Esophageal TTS StentTaewoong Medical Co., Ltd.20213—
+4K202973HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd.20212—
+4K183396HANAROSTENT FASTTM Biliary (NNN)M.I.Tech Co., Ltd.20190—
+4K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+4K140760Bonastent BiliaryEndochoice, Inc.20140—
+4K140630Wallflex Biliary RX Stent SystemBoston Scientific201431
+4K123205Esophageal TTS StentTaewoong Medical Co., Ltd.201391
+4K032137Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp.200301
+5K242845EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc.20250—
+5K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific20241—
+5K240522Esophageal TTS StentTaewoong Medical20241—
+5K223469WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation20231—
+5K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+5K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.20200—
+5K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+6K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.20250—
+6K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific20240—
+6K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+6K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+7K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—