# K100430: Urgotul AG, Antimicrobial Wound Dressing with Silver

- Pathway: 510(k) (Special)
- Applicant: Laboratoires Urgo
- Decided: Jun 11, 2010 after 115 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: 5 generations back to K970566 (1997). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061220: Urgotul AG, Laboratoires Urgo (2006) Summary page 1.
- K062559: Urgocell AG Antimicrobial Wound Dressing with Silver, Laboratoires Urgo (2007) Summary page 1.

## Most influential descendants
- K242758: Atrauman® Ag (2024), 0 descendants of its own
- K130040: Mepitel AG (2014), 0 descendants of its own

## Indications for use
The barrier functions of Urgotul Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.

Source page: https://510kreport.com/device/K100430
Methodology: https://510kreport.com/methodology