# K123219: Urgoclean Absorbent Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Laboratoires Urgo
- Decided: Mar 18, 2013 after 154 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)
- K982116: Aquacel Hydrofiber Wound Dressing, Convatec, A Bristol-Myers Squibb Co. (1998) Summary page 1.
- 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 1.
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2008) Summary page 1.

## Indications for use
Urgoclean Absorbent Wound Dressing is indicated to manage all exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage ll-IV), diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological); partial thickness bums; management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided.

Source page: https://510kreport.com/device/K123219
Methodology: https://510kreport.com/methodology