510(k) Report

Devices descending from K101530

4 later devices reach Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredCook Ireland, Ltd.20172—
+1K113510Evolution Colonic Stent SystemCook Ireland, Ltd.20123—
+2K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…Boston Scientific Corporation20201—
+3K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…Boston Scientific Corporation20240—