510(k) Report

Devices descending from K955347

66 later devices reach Ultraflex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp200815—
+1K032930Ultraflex Esophageal NG Stent SystemBoston Scientific Corp20036516
+2K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+2K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+2K093537Hanarostent Esophagus (CCC)M.I.Tech Co., Ltd.20100—
+2K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+2K091816Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation200979
+2K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation200914—
+2K080359Evolution Esophageal Stent SystemCook Ireland, Ltd.20082—
+2K043260Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC200514—
+2K051621Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc.200519—
+2K041648Niti-S Stent & Introducer, Model EoxxxxTaewoong Medical Co., Ltd.200527—
+3K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+3K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+3K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20183—
+3K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd.20160—
+3K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+3K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+3K142339HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC20140—
+3K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation20132—
+3K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp20125—
+3K111575Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc.20126—
+3K120983Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation20123—
+3K113627Hemasorb Resorbable Hemostatic Bone PuttyOrthocon20121—
+3K111611Endomaxx Fully Covered Esophageal StentMerit Medical Systems, Inc.20111—
+3K102762Orthostat Bone Hemostat Matrix ApplicatorOrthocon, Inc.20119—
+3K093619Evolution Esophageal Stent Fully Covered, Models Evo-FC-18-23-8-E, Evo-FC-18-23-10-E…Cook Ireland, Ltd.20101—
+3K091121OrthostatOrthocon, Inc.200910—
+3K080782Niti-S Esophageal StentTaewoong Medical Co., Ltd.2009151
+3K073667Niti-S Biliary StentTaewoong Medical Co., Ltd.200823—
+3K080838Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc.200817—
+3K063330Orthocon Hemasorb Resorbable Hemostatic Bone PuttyOrthocon, Inc.20061—
+3K060987OSCERA7 Synthetic Absorbable Bone Wax, Model OS31Cp Medical20060—
+3K060239Aleolus/Enoventions,Alimaxx-E DV Esophageal Stent SystemAlveolus, Inc.20060—
+4K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—
+4K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20250—
+4K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.20250—
+4K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.20250—
+4K223266Hilzo Esophageal StentsThoracent, Inc.20240—
+4K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20233—
+4K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+4K223626Niti-S Biliary Speed D StentTaewoong Medical Co., Ltd.20230—
+4K221071Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20221—
+4K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.20212—
+4K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+4K142348OsteoSeal Bone HemostatHemostasis, LLC20150—
+4K123205Esophageal TTS StentTaewoong Medical Co., Ltd.201391
+4K121953Hemasorb ApplyOrthocon, Inc.20120—
+4K113551Esophageal TTS StentTaewoong Medical Co., Ltd.2012101
+4K111149Hanarostent Biliary (NNN)M.I.Tech Co., Ltd.20116—
+4K111524MP 719Marine Polymer Technologies, Inc.20110—
+4K093003Bonastent BiliaryEndochoice, Inc.20103—
+5K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.20250—
+5K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+5K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20231—
+5K223354EGIS Biliary Single Bare StentS&G Biotech, Inc.20231—
+5K221482Esophageal TTS StentTaewoong Medical Co., Ltd.20222—
+5K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.20210—
+5K211706Esophageal TTS StentTaewoong Medical Co., Ltd.20213—
+5K202973HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd.20212—
+5K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.20200—
+5K183396HANAROSTENT FASTTM Biliary (NNN)M.I.Tech Co., Ltd.20190—
+5K140760Bonastent BiliaryEndochoice, Inc.20140—
+6K242845EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc.20250—
+6K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+6K240522Esophageal TTS StentTaewoong Medical20241—