# K153723: ACTICOAT Surgical Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: Sep 14, 2016 after 261 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 K914579 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050030: Acticoat Moisture Control Dressing, Smith & Nephew, Inc. (2005) Summary page 5.
- K083113: Acticoat Flex 7 Dressing, Smith & Nephew, Inc. (2009) Summary page 5.

## Indications for use
ACTICOAT Surgical dressing is indicated for use in light to moderately exuding full and partial thickness wounds including decubitus ulcers, diabetic ulcers, surgical wounds, 1st and 2nd degree burns, and donor sites. ACTICOAT Surgical dressing may be used over debrided and full and partial thickness wounds.

Source page: https://510kreport.com/device/K153723
Methodology: https://510kreport.com/methodology