K223259 is an FDA 510(k) clearance for the coactiv+™ Antimicrobial Wound Gel. This device is classified as a Dressing, Wound, Drug.
Submitted by Kane Biotech, Inc. (Winnipeg, CA). The FDA issued a Cleared decision on May 24, 2023, 212 days after receiving the submission on October 24, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K223259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2022 |
| Decision Date | May 24, 2023 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |