510(k) Report

Devices descending from K173400

2 later devices reach ORISE Tissue Retractor System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182540DiLumen Endolumenal Interventional PlatformLumendi, LLC20181—
+2K210851DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC20210—