510(k) Report

Devices descending from K111149

6 later devices reach Hanarostent Biliary (NNN) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223354EGIS Biliary Single Bare StentS&G Biotech, Inc.20231—
+1K202973HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd.20212—
+1K183396HANAROSTENT FASTTM Biliary (NNN)M.I.Tech Co., Ltd.20190—
+2K242845EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc.20250—
+2K221071Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20221—
+3K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.20250—