# K231057: Antibacterial Gel Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Winner Medical Co., Ltd.
- Decided: Dec 1, 2023 after 232 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: 1 generation back to K083103 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083103: Acryderm Antimicrobial Silver Gel Wound Dressing Model #B, Acrymed, Inc. (2009) Summary page 4.

## Indications for use
Under the supervision of a healthcare professional, Antibacterial Gel Wound Dressing is indicated for the management of first and superficial second degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. Antibacterial Gel Wound Dressing is intended for the management of minor abrasions, cuts, lacerations and scalds.

Source page: https://510kreport.com/device/K231057
Methodology: https://510kreport.com/methodology