510(k) Report

Devices descending from K180606

3 later devices reach SOMAVAC Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222856SOMAVAC 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc.20222—
+2K231063SOMAVAC® 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc.20230—
+2K223373Enivo™Aroa Biosurgery, Ltd.20230—