510(k) Report

Devices descending from K190141

2 later devices reach HANAROSTENT LowAx Colon/Rectum (NNN) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.20231—
+2K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.20250—