# K070581: Silver Alginate II Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions Limited
- Decided: Jul 13, 2007 after 134 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 K914575 (1991). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041316: Antimicrobial Alginate Dressing, Advanced Medical Solutions, Ltd. (2004) Summary page 1.
- K013814: Absorbent Antimicrobial Wound Dressing, Convatec, A Division of E.R. Squibb & Sons (2002) Summary page 1.
- K002896: Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing, The Westaim Corp. (2001) Summary page 1.

## Most influential descendants
- K090453: Silver Alginate 11 Wound Dressing (2009), 0 descendants of its own
- K080503: Silver Alginate IV Antimicrobial Wound Dressing (2008), 0 descendants of its own
- K081363: Non-Adherent Antimicrobial Alginate Dressing, Silvercel Non-Adherent Antimicrobial Alginate Dressing (2008), 0 descendants of its own

## Indications for use
Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as: * Post-operative wounds * Trauma wounds (dermal lesions, trauma injuries or incisions) * Leg Ulcers * Pressures Ulcers * Diabetic Ulcers * Graft and donor sites * Post-operative surgical wounds * 1st and 2nd degree burns * Partial and Full Thickness wounds Silver Alginate II Dressing is indicated for external use only

Source page: https://510kreport.com/device/K070581
Methodology: https://510kreport.com/methodology