510(k) Report

Devices descending from K161599

4 later devices reach UNO Negative Pressure Wound Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+2K190028UNO 30Genadyne Biotechnologies20201—
+2K181929MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc.20190—
+3K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—