# K061220: Urgotul AG

- Pathway: 510(k) (Traditional)
- Applicant: Laboratoires Urgo
- Decided: Jul 27, 2006 after 87 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: 3 generations back to K970566 (1997). 6 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013525: Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM), Coloplast Corp. (2002) Summary page 1.
- K001519: Acticoat 7 Dressing, Westaim Biomedical, Inc. (2000)

## Most influential descendants
- K062559: Urgocell AG Antimicrobial Wound Dressing with Silver (2007), 6 descendants of its own
- K100430: Urgotul AG, Antimicrobial Wound Dressing with Silver (2010), 2 descendants of its own
- K072378: Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625, AR-1626 (2007), 1 descendant of its own
- 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 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/K061220
Methodology: https://510kreport.com/methodology