510(k) Report

Devices descending from K161897

8 later devices reach PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management…Kci USA, Inc.20190—
+1K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc.20191—
+1K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc.20185—
+1K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc.20187—
+2K223263Prevena Plus 125 Therapy Unit3M202301
+2K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group20220—
+2K202217Kendall NPWT Incision Management DeviceCardinalhealth20210—
+2K191101Kendall NPWT Incision Management Dressing KitCardinalhealth20200—