510(k) Report

Devices descending from K162428

7 later devices reach DiLumen Endolumenal Interventional Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213773Insufflation Retention DeviceBpendo, LLC20221—
+1K173317DiLumen C2; DiLumen Tool MountLumendi, LLC20184—
+2K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLC20260—
+2K211819DiLumen C2 and Tool MountLumendi, LLC20213—
+3K221452DiLumen C1, EZ1 and Tool MountLumendi, LLC20232—
+4K231323Ancora-SBAspero Medical, Inc.20231—
+5K260314Ancora-SBAspero Medical, Inc.20260—