# K091034: Aquacel AG Surgical

- Pathway: 510(k) (Traditional)
- Applicant: Convatec
- Decided: Dec 16, 2009 after 250 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: 4 generations back to K914604 (1992). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 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 1.
- K891696: Duoderm* Extra Thin Flexible Hydrocolloid Dressing, Convatec, A Division of E.R. Squibb & Sons (1989) Summary page 1.

## Most influential descendants
- K180634: Surgical Silver Post Operative Dressing (2018), 0 descendants of its own
- K152926: AQUACEL Ag Surgical SP Dressing (2016), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional: AQUACEL® Ag Surgical may be used for the management of wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.

Source page: https://510kreport.com/device/K091034
Methodology: https://510kreport.com/methodology