Skip to content

Avance Foam Dressing Kits

by Molnlycke Health Care Us, LLC 510(k)

Active United States

510(k) K141847

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141847 Date26 Mar 2015ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 19 Sep 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 Kits are classified as Negative Pressure Wound Therapy (NPWT) Dressings under FDA regulation 878.4780. These kits are designed to promote wound healing by applying controlled negative pressure to the wound bed, facilitating granulation tissue formation and reducing excess fluid accumulation. The foam dressings are intended for use in acute and chronic wounds, including surgical incisions, traumatic wounds, and partial-thickness burns.

The kits are supplied as single-use, sterile devices and are intended for use in clinical settings such as hospitals, surgical centers, and outpatient care facilities. They are regulated under FDA 510(k) clearance (K141847) and fall under Class II medical devices. Each kit includes components for application, securing, and maintaining negative pressure therapy, with no indication of MRI compatibility. Storage requirements are consistent with standard sterile medical dressings.

Other devices from Molnlycke Health Care Us, LLC

See all devices from Molnlycke Health Care Us, LLC →