# K123481: Aquacel AG Foam Hydrofiber Foam Dressing with Silver, Adhesive and Non Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, Inc.
- Decided: Jun 6, 2013 after 205 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K914604 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2008) Summary page 2.
- K100029: Mepilex Border AG Dressing, Molnlycke Health Care (2010) Summary page 1.
- (no number) AQUACEL™ Foam Hydrofiber™ Foam Dressing (Adhesive and Non-Adhesive), NAC: named in the summary without a submission number

## Recalls of this device
- Nov 15, 2022 · Class II · Z-0723-2023: ConvaTec are voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings

## Indications for use
Under the supervision of a healthcare professional: AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, adhesive and non adhesive may be used for the management of both chronic and acute wounds, such as: - Partial thickness (second degree) burns; - Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); - Surgical wounds - Traumatic wounds; - Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; - Abrasions; - Lacerations; - Minor Cuts; - Minor scalds and burns.

Source page: https://510kreport.com/device/K123481
Methodology: https://510kreport.com/methodology