# K161289: DURAFIBER Ag

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: Aug 3, 2016 after 86 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: 5 generations back to K914604 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103793: Durafiber AG, Smith & Nephew, Inc. (2011) Summary page 5.

## Indications for use
DURAFIBER Ag is an effective antimicrobial dressing that is intended to provide a moist wound environment for use in the management of partial and full thickness wounds including first and second degree burns. Appropriate wounds types include: - Chronic wounds including diabetic ulcers, leg ulcers, pressure ulcers and sores (partial & full thickness); - surgical wounds left to heal by secondary intent; - traumatic wounds; - wounds that are prone to minor bleeding, such as wounds that have been mechanically or surgically debrided.

Source page: https://510kreport.com/device/K161289
Methodology: https://510kreport.com/methodology