# K251929: SilverCeuticals® Antimicrobial Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Silverceuticals, Inc.
- Decided: Jun 24, 2026 after 366 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: 2 generations back to K083103 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211123: LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel, Huizhou Foryou Medical Devices Co., Ltd. (2022) Summary page 5.

## Indications for use
The device is indicated for the OTC local management of: minor burns, minor lacerations, minor abrasions, minor cuts, It is prescription indicated by healthcare practitioner for the management of: wounds such as 1st and partial-thickness 2nd degree burns, stasis ulcers, pressure ulcers, diabetic ulcers, device insertion site wounds, surgical incision sites, graft sites, donor sites, and skin tears.

Source page: https://510kreport.com/device/K251929
Methodology: https://510kreport.com/methodology