510(k) Report

Devices descending from K962899

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012883Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…Boston Scientific Corp20012146
+2K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp20125—
+2K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+2K072094ChoostentM.I.Tech Co., Ltd.20085—
+2K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp200815—
+3K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+3K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+3K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20190—
+3K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+3K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+3K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+3K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation20132—
+3K093537Hanarostent Esophagus (CCC)M.I.Tech Co., Ltd.20100—
+3K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation200914—
+4K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+4K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+4K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+4K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20183—
+5K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—
+5K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.20212—
+6K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.20250—
+6K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.20210—