510(k) Report

Devices descending from K080550

4 later devices reach Megachannel Endoscopic Overtube, Model OT22 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153698LumenR Tissue Retractor SystemLumenr, LLC20163—
+2K173400ORISE Tissue Retractor SystemBoston Scientific20182—
+3K182540DiLumen Endolumenal Interventional PlatformLumendi, LLC20181—
+4K210851DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC20210—