# K103793: Durafiber AG

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: May 2, 2011 after 126 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). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2008) Summary page 2.
- K083113: Acticoat Flex 7 Dressing, Smith & Nephew, Inc. (2009) Summary page 2.

## Most influential descendants
- K161289: DURAFIBER Ag (2016), 0 descendants of its own

## 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 wounds of partial and full thickness wounds including first and second degree burns. Examples of wound types which indicated are: * 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/K103793
Methodology: https://510kreport.com/methodology