510(k) Report

Devices descending from DEN180013

2 later devices reach PREVENA 125 and PREVENA PLUS 125 Therapy Units through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223263Prevena Plus 125 Therapy Unit3M202301
+1K203716PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative…Smith and Nephew Medical Limited20210—