# K100429: Urgocell 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.
No later device cites it as a predicate yet.
0 of 15 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.

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

Source page: https://510kreport.com/device/K100429
Methodology: https://510kreport.com/methodology