V.A.C. Therapy System

• • Ongoing Z-1176-2025 FDA Class II ·initiated 17 Jan 2025

  Due to increase in complaints related to leak alarms

• • Terminated Z-0666-2010 FDA Unclassified (pre-2012) ·initiated 4 Nov 2009

  Power cords may crack and fail inside plug with potential for fire hazard.

510(k) Number

K062227 ↗

FDA Product Code

OMP

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

  Class II

  FDA 510(k) K160451 Active Cleared 20 Jun 2016

• Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing,

  Class II

  FDA 510(k) K141017 Active Cleared 20 Aug 2015

• Prevena Incision Management System with Customizable Dressing

  Class II

  FDA 510(k) K123878 Active Cleared 15 Jan 2013

• Prevena Incision Management System with Customizable Dressing, Prevena Incision Managemant System with Peel& Place Dres

  Class II

  FDA 510(k) K133232 Active Cleared 24 Mar 2014

• V.A.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model V.A.C. Ulta Therapy Unit Model U

  Class II

  FDA 510(k) K100657 Active Cleared 17 Sep 2010

• V.A.C.ULTA Negative Pressure Wound Therapy System Open recall

  Class II

  FDA 510(k) K162790 Active Cleared 26 Jan 2017

See all devices from Kci USA, Inc. (Kinetic Concepts, Inc.) →