# K100693: Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products Limited
- Decided: Aug 10, 2010 after 152 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914575 (1991). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070175: Aquanova Super-Absorbent Gelling Dressing, Otc, Medtrade Products, Ltd. (2007) Summary page 1.
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2008) Summary page 1.

## Most influential descendants
- K102965: Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma Gauze AG, Omni-Stat Hemostatic Anti (2010), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional AQUANOVA Ag may be used for the management of partial and full thickness wounds 1st and 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.

Source page: https://510kreport.com/device/K100693
Methodology: https://510kreport.com/methodology