# K223259: coactiv+™ Antimicrobial Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Kane Biotech, Inc.
- Decided: May 24, 2023 after 212 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: 7 generations back to K914604 (1992). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130857: Prontosan Wound Gel X, B.Braun Medical, Inc. (2013) Summary page 4.
- K192527: Rochal Antimicrobial Wound Gel, Rochal Industries, LLC (2020) Summary page 4.

## Most influential descendants
- K241809: coactiv+™ Antimicrobial Wound Gel (2024), 0 descendants of its own

## 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/K223259
Methodology: https://510kreport.com/methodology