V.A.C. Granufoam Silver Dressing

No FDA recalls found in the data synced 22 Oct 2026.

Full name

V.A.C. Granufoam Silver Small Dressing; V.A.C. Granufoam Silver Medium Dressing; V.A.C. Granufoam Silver Large Dressing

510(k) Number

K102956 ↗

FDA Product Code

OMP

Models / Variants

V.A.C. Granufoam Silver Small Dressing

V.A.C. Granufoam Silver Medium Dressing

V.A.C. Granufoam Silver Large Dressing

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.) →

• What is the primary function of the V.A.C. Granufoam Silver Dressing?

  This device is designed as an accessory for negative pressure wound therapy powered suction pumps. It incorporates micro-bonded silver throughout the foam to provide antimicrobial benefits during the wound healing process.

• What size options are available for this dressing?

  The V.A.C. Granufoam Silver Dressing is manufactured in three distinct sizes: small, medium, and large, to accommodate different wound dimensions.

• How is this device regulated?

  The V.A.C. Granufoam Silver Dressing is regulated under FDA 510(k) clearance, which indicates that the device has been found substantially equivalent to other legally marketed predicate devices.