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Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam

by Molnlycke Health Care

510(k) K122132

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122132 Date17 Jan 2013ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OMP
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Avance Foam Dressing Kit is a negative pressure wound therapy (NPWT) dressing system designed to promote wound healing by applying controlled suction to the wound bed. It consists of open-cell, hydrophobic polyurethane foam dressings that facilitate exudate removal, support granulation tissue formation, and maintain a moist wound environment. The transparent film component helps monitor wound progress while minimizing patient discomfort, and the transfer pad aids in secure application.

This sterile, single-use device is intended for use in clinical settings such as general and plastic surgery. Available in three sizes (Small, Medium, Large), it is supplied as a complete kit and has received FDA 510K clearance under the classification of Class II medical devices (regulation number 878.4780). Proper storage requires protection from moisture and extreme temperatures, and it must be used within the manufacturer’s specified expiration date.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Avance Foam Dressing Kit used for?

    The Avance Foam Dressing Kit is designed for negative pressure wound therapy (NPWT) to promote wound healing. It applies controlled suction to the wound bed, facilitating exudate removal, supporting granulation tissue formation, and maintaining a moist environment—ideal for clinical settings like general and plastic surgery.

  • How is the Avance Foam Dressing Kit supplied and what sizes are available?

    The kit is supplied as a complete, sterile, single-use system and includes open-cell polyurethane foam dressings, a transparent film, and a transfer pad. It comes in three sizes: Small, Medium, and Large, ensuring compatibility with various wound sizes.

  • Is the Avance Foam Dressing Kit reusable or single-use?

    The Avance Foam Dressing Kit is explicitly designed for single-use only. This ensures sterility and reduces the risk of cross-contamination, adhering to best practices for wound care and infection prevention.

  • How should the Avance Foam Dressing Kit be stored?

    The kit must be stored in a dry environment, protected from moisture and extreme temperatures. It should also be kept within the manufacturer’s specified expiration date to maintain its efficacy and sterility.

  • What distinguishes the transparent film in this kit?

    The transparent film allows clinicians to monitor wound progress visually without removing the dressing, minimizing patient discomfort and reducing the risk of infection from repeated exposure. This feature is particularly useful for tracking healing over time.