510(k) Report

Devices descending from K211819

3 later devices reach DiLumen C2 and Tool Mount through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221452DiLumen C1, EZ1 and Tool MountLumendi, LLC20232—
+2K231323Ancora-SBAspero Medical, Inc.20231—
+3K260314Ancora-SBAspero Medical, Inc.20260—