510(k) Report

Devices descending from K080359

2 later devices reach Evolution Esophageal Stent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd.20160—
+1K093619Evolution Esophageal Stent Fully Covered, Models Evo-FC-18-23-8-E, Evo-FC-18-23-10-E…Cook Ireland, Ltd.20101—