V.A.C.ULTA Negative Pressure Wound Therapy System

• • Ongoing Z-0507-2025 FDA Class II ·initiated 5 Nov 2024

  Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.

510(k) Number

K162790 ↗

FDA Product Code

OMP

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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

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• 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

• Abthera Open Abdomen Negative Pressure Therapy System

  Class II

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