510(k) Report

Devices descending from K122132

21 later devices reach Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151263Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd.20161—
+1K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC201514—
+1K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care20143—
+2K182191Invia Abdominal Dressing KitMedela AG20190—
+2K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+2K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC20161—
+2K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC20160—
+2K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC20160—
+2K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+2K152741Mepiseal Soft Silicone SealantMolnlycke Health Care Us, LLC20160—
+2K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+3K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+3K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+3K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+3K180415Invia White Foam NPWTMedela AG20180—
+3K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+4K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+4K223388Invia® Integrated DressingMedela AG20230—
+4K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+4K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+5K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—