510(k) Report

Devices descending from K971548

156 later devices reach Ambuvac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management…Kci USA, Inc.20190—
+5K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+5K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc.20191—
+5K182191Invia Abdominal Dressing KitMedela AG20190—
+5K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+5K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+5K180415Invia White Foam NPWTMedela AG20180—
+5K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc.20185—
+5K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc.20187—
+5K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative…Kci USA, Inc.20180—
+5K162610NEXA Negative Pressure Wound Therapy SystemNexa Medical, Ltd.20170—
+5K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited201711—
+5K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+5K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC20161—
+5K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+5K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.201623—
+5K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc.20130—
+5K102001Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc.2010143
+6K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete…3M Healthcare Business Group20230—
+6K223263Prevena Plus 125 Therapy Unit3M202301
+6K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+6K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group20220—
+6K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC20210—
+6K202217Kendall NPWT Incision Management DeviceCardinalhealth20210—
+6K200223PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC20200—
+6K191101Kendall NPWT Incision Management Dressing KitCardinalhealth20200—
+6K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+6K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+6K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+6K180205AVELLE Negative Pressure Wound Therapy SystemConvatec Limited20183—
+6K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20186—
+6K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20188—
+6K172521PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20171—
+6K172519PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20170—
+6K161599UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20174—
+6K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc.2015121
+6K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.201313—
+7K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building20260—
+7K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…Smith & Nephew Medical, Ltd.20251—
+7K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+7K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+7K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingSmith & Nephew Medical Limited20220—
+7K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…Smith & Nephew Medical Limited20201—
+7K190028UNO 30Genadyne Biotechnologies20201—
+7K191760PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20192—
+7K181929MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc.20190—
+7K182323PICO 7Y Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20190—
+7K180614PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20180—
+7K162129RENASYS-G Gauze Dressing Kits with Soft PortSmith & Nephew, Inc.20160—
+7K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.20150—
+8K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—
+8K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.20250—
+8K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+8K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+8K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+9K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—