# K152926: AQUACEL Ag Surgical SP Dressing

- Pathway: 510(k) (Special)
- Applicant: Convatec Limited
- Decided: Jan 21, 2016 after 108 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: 5 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)
- K091034: Aquacel AG Surgical, Convatec (2009) Summary page 4.

## Recalls of this device
- Jun 8, 2026 · Class II · Z-2677-2026: Surgical dressing manufactured out of specification (greater thickness).

## Indications for use
AQUACEL® Ag Surgical SP 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/K152926
Methodology: https://510kreport.com/methodology