510(k) Report

Devices descending from K925406

35 later devices reach Biliary Endoprostheses W/Unistep Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081956Medinol X-Suit Nir Biliary Metallic StentMedinol, Ltd.20090—
+1K061231Wellflex Biliary RX Stent SystemBoston Scientific Corp200610—
+1K962899Ultraflex DiamondBoston Scientific Corp199722—
+2K121430Evolution Biliary Stent SystemCook Ireland, Ltd.20130—
+2K122072Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered)…Boston Scientific Corporation20124—
+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—
+2K08173310MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890Boston Scientific Corp20087—
+2K012883Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…Boston Scientific Corp20012146
+3K140630Wallflex Biliary RX Stent SystemBoston Scientific201431
+3K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp20125—
+3K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+3K072094ChoostentM.I.Tech Co., Ltd.20085—
+3K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp200815—
+4K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific20241—
+4K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+4K223469WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation20231—
+4K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+4K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20190—
+4K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+4K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+4K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+4K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation20132—
+4K093537Hanarostent Esophagus (CCC)M.I.Tech Co., Ltd.20100—
+4K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation200914—
+5K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific20240—
+5K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+5K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+5K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+5K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20183—
+6K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—
+6K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.20212—
+7K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.20250—
+7K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.20210—