510(k) Report

Devices descending from K110647

48 later devices reach Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc.2015121
+1K143301NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA KitIntegrated Healing Technologies20150—
+1K142956NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome KitIntegrated Healing Technologies20150—
+1K123507Kci NPWT Gauze DressingKci USA, Inc.201311—
+1K122132Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…Molnlycke Health Care201321—
+1K110078ExtricareDevon Medical Products, Inc.20129—
+1K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc.201110—
+2K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…Smith & Nephew Medical, Ltd.20251—
+2K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingSmith & Nephew Medical Limited20220—
+2K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+2K162129RENASYS-G Gauze Dressing Kits with Soft PortSmith & Nephew, Inc.20160—
+2K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd.20165—
+2K151263Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd.20161—
+2K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+2K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.20150—
+2K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC201514—
+2K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+2K132225ExtricareDevon Medical, Inc.20148—
+2K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care20143—
+3K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.20250—
+3K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.20240—
+3K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices20230—
+3K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.20210—
+3K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+3K182191Invia Abdominal Dressing KitMedela AG20190—
+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—
+3K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC20173—
+3K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC20161—
+3K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC20160—
+3K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC20160—
+3K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+3K152741Mepiseal Soft Silicone SealantMolnlycke Health Care Us, LLC20160—
+3K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+4K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+4K223388Invia® Integrated DressingMedela AG20230—
+4K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+4K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+4K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+4K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+4K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+4K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+4K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+5K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+5K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+6K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—