K240552 is an FDA 510(k) clearance for the Irrisept Antimicrobial Wound Lavage, a Dressing, Wound, Drug, submitted by Irrimax Corporation (Lawrenceville, US). The FDA issued a Cleared decision on June 18, 2024, 111 days after receiving the submission on February 28, 2024. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K240552 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 28, 2024 |
| Decision Date | June 18, 2024 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |