# K171225: Sorbact Wound Dressing-Ribbon Gauze

- Pathway: 510(k) (Traditional)
- Applicant: Abigo Medical AB
- Decided: Aug 21, 2017 after 117 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 K002599 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063059: Sorbact Wound Dressing, Abigo Medical AB (2007) Summary page 4.

## Indications for use
Sorbact Ribbon Gauze is intended for use in the management of exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). Sorbact Ribbon Gauze is indicated for shallow cavity wounds and fistulas.

Source page: https://510kreport.com/device/K171225
Methodology: https://510kreport.com/methodology