K210536 is an FDA 510(k) clearance for the Irrisept Antimicrobial Wound Lavage, a Lavage, Jet (Class II — Special Controls, product code FQH), submitted by Irrimax Corporation (Lawrenceville, US). The FDA issued a Cleared decision on May 28, 2021, 93 days after receiving the submission on February 24, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K210536 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 2021 |
| Decision Date | May 28, 2021 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| 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 |