510(k) Report

Devices descending from K162790

3 later devices reach V.A.C.ULTA Negative Pressure Wound Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233614Genadyne DUO NPWTGenadyne Biotechnologies, Inc.20240—
+1K203316V.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part of 3M Health Care Business Group20211—
+2K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.20260—