510(k) Report

Devices descending from K022011

17 later devices reach V.a.C. Abdominal Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100787Renasys F/-AB Abdominal Wound Dressing KitSmith & Nephew, Inc.201011—
+1K090489Abthera Open Abdomen Dressing, Model: M8275026Kci USA, Inc.20091—
+1K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc.20091—
+1K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)200632
+2K121817Vcare aIVT Medical, Ltd.20130—
+2K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20120—
+2K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc.201110—
+3K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+3K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care20143—
+4K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+4K182191Invia Abdominal Dressing KitMedela AG20190—
+4K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+4K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC20161—
+5K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+5K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+6K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+7K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—