510(k) Report

Devices descending from K061919

107 later devices reach Versatile 1 Ezcare Wound Vacuum System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180614PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20180—
+7K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+7K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+7K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+7K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+8K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—
+8K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—