# K143017: Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver

- Pathway: 510(k) (Traditional)
- Applicant: Laboratoires Urgo
- Decided: Aug 7, 2015 after 291 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 K914604 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063271: Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated Antimicrobial Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2007) Summary page 4.
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2008) Summary page 4.

## Indications for use
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver is indicated to manage exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, dermatological); partial thickness burns; traumatic wounds; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided. The dressing also provides an antibiotic barrier for bacterial penetration of the dressing, which may help reduce infection.

Source page: https://510kreport.com/device/K143017
Methodology: https://510kreport.com/methodology