510(k) Report

Devices descending from K143133

5 later devices reach RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+1K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+2K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+3K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+4K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—