510(k) Report

Devices descending from K102001

14 later devices reach Modification to Renasys EZ Plus Negative Pressure Wound Therapy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+1K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc.2015121
+1K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.201313—
+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—
+2K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+2K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+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—
+2K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.20150—
+3K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.20250—
+3K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+4K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+5K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—