510(k) Report

Devices descending from K983753

19 later devices reach Star Temporary Wound Cover through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093166Wittmann PatchAperta, LLC200902
+1K022011V.a.C. Abdominal DressingKinetic Concepts, Inc.2003171
+2K100787Renasys F/-AB Abdominal Wound Dressing KitSmith & Nephew, Inc.201011—
+2K090489Abthera Open Abdomen Dressing, Model: M8275026Kci USA, Inc.20091—
+2K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc.20091—
+2K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)200632
+3K121817Vcare aIVT Medical, Ltd.20130—
+3K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20120—
+3K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc.201110—
+4K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+4K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care20143—
+5K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+5K182191Invia Abdominal Dressing KitMedela AG20190—
+5K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+5K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC20161—
+6K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+6K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+7K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+8K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—