510(k) Report

Devices descending from K222856

2 later devices reach SOMAVAC 100 Sustained Vacuum System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231063SOMAVAC® 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc.20230—
+1K223373Enivo™Aroa Biosurgery, Ltd.20230—