510(k) Report

Devices descending from K180855

5 later devices reach Prevena Plus Incision Management System, Prevena Plus Duo Incision Management… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223263Prevena Plus 125 Therapy Unit3M202301
+1K202217Kendall NPWT Incision Management DeviceCardinalhealth20210—
+1K191101Kendall NPWT Incision Management Dressing KitCardinalhealth20200—
+1K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc.20191—
+2K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group20220—