# K241809: coactiv+™ Antimicrobial Wound Gel

- Pathway: 510(k) (Special)
- Applicant: Kane Biotech, Inc.
- Decided: Jul 19, 2024 after 28 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: 8 generations back to K914604 (1992). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223259: coactiv+™ Antimicrobial Wound Gel, Kane Biotech, Inc. (2023) Summary page 5.

## Indications for use
Rx: The coactiv+™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds, large surface area wounds and surgical incisions for adult populations. OTC: The coactiv+™ Antimicrobial Wound Gel is indicated for management of minor cuts, minor lacerations, minor burns (1st degree burns) and abrasions for adult populations.

Source page: https://510kreport.com/device/K241809
Methodology: https://510kreport.com/methodology