510(k) Report

Devices descending from K141847

14 later devices reach Avance Foam Dressing Kits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+1K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC20160—
+1K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+1K152741Mepiseal Soft Silicone SealantMolnlycke Health Care Us, LLC20160—
+1K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+2K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+2K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+2K180415Invia White Foam NPWTMedela AG20180—
+2K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+3K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+3K223388Invia® Integrated DressingMedela AG20230—
+3K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+3K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+4K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—