# K153674: Sorbact Foam Gentle Border, Sorbact Superabsorbent

- Pathway: 510(k) (Traditional)
- Applicant: Abigo Medical AB
- Decided: Jul 1, 2016 after 193 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 K002599 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143151: Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact), Bsn Medical GmbH (2015) Summary page 4.
- K063059: Sorbact Wound Dressing, Abigo Medical AB (2007) Summary page 4.

## Indications for use
Rx.: Sorbact® Foam Gentle Border is indicated for use in the management of moderately exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds. Rx.: Sorbact® Superabsorbent is indicated for use in the management of heavily exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.

Source page: https://510kreport.com/device/K153674
Methodology: https://510kreport.com/methodology