510(k) Report

Devices descending from K153698

3 later devices reach LumenR Tissue Retractor System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173400ORISE Tissue Retractor SystemBoston Scientific20182—
+2K182540DiLumen Endolumenal Interventional PlatformLumendi, LLC20181—
+3K210851DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC20210—