K222804 is an FDA 510(k) clearance for the Irrisept Antimicrobial Wound Lavage. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Irrimax Corporation (Lawrenceville, US). The FDA issued a Cleared decision on September 22, 2022, 6 days after receiving the submission on September 16, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K222804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2022 |
| Decision Date | September 22, 2022 |
| Days to Decision | 6 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FQH - Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |