510(k) Report

Devices descending from K052456

127 later devices reach Modification to Versatile 1 Wound Vacuum System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223388Invia® Integrated DressingMedela AG20230—
+6K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+6K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+6K211277Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc.20211—
+6K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…Smith & Nephew Medical Limited20201—
+6K190028UNO 30Genadyne Biotechnologies20201—
+6K191760PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20192—
+6K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+6K181929MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc.20190—
+6K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+6K182191Invia Abdominal Dressing KitMedela AG20190—
+6K182323PICO 7Y Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20190—
+6K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+6K180614PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20180—
+6K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC20161—
+6K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC20160—
+6K152741Mepiseal Soft Silicone SealantMolnlycke Health Care Us, LLC20160—
+6K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+7K232379PREVENT KitClear Choice Therapeutics20240—
+7K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+7K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+7K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+7K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+7K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+8K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—
+8K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+9K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—