510(k) Report

Devices descending from K060323

11 later devices reach Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061877Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemBoston Scientific Corp200610—
+2K201159WallFlex Colonic Stent System with Anchor Lock Delivery SystemBoston Scientific Corporation20201—
+2K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…Boston Scientific Corporation20201—
+2K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.20184—
+2K113510Evolution Colonic Stent SystemCook Ireland, Ltd.20123—
+3K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…Boston Scientific Corporation20240—
+3K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.20193—
+3K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredCook Ireland, Ltd.20172—
+4K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.20231—
+4K190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd.20192—
+5K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.20250—