510(k) Report

Devices descending from K160725

4 later devices reach EndoFLIP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183072EndoFLIP SystemCrospon, Ltd.201921
+1K170833EndoFLIP® System with FLIP Topography moduleCrospon, Ltd.20170—
+2K223705EndoflipTM 300Covidien, LLC20231—
+3K231861EndoflipTM 300 SystemCovidien, LLC20230—