# K063059: Sorbact Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Abigo Medical AB
- Decided: Apr 19, 2007 after 196 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: 2 generations back to K002599 (2000). 6 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052696: Covaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing, Covalon Technologies, Ltd. (2006) Summary page 1.
- K051542: Triosyn T40 Antimicrobial Wound Dressing, Triosyn Corp. (2006) Summary page 1.

## Most influential descendants
- K143151: Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) (2015), 1 descendant of its own
- K171225: Sorbact Wound Dressing-Ribbon Gauze (2017), 0 descendants of its own
- K153674: Sorbact Foam Gentle Border, Sorbact Superabsorbent (2016), 0 descendants of its own
- K100591: Sorbact (2011), 0 descendants of its own

## Indications for use
Rx: Sorbact® Wound Dressings are intended for use in the management of moderate to heavily exudating partial to full thickness wounds (including clean, colonized, contaminated or infected wounds) and to bind hydrophobic microbes. The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers. Sorbact® Wound Dressings are intended for over-the-counter use in the management of draining minor wounds and to attract and bind water repelling germs. The dressings may be used on minor scrapes, cuts, sores and burns

Source page: https://510kreport.com/device/K063059
Methodology: https://510kreport.com/methodology