K210987 is an FDA 510(k) clearance for the IRRIGO Wound Wash Jet System. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Inopro, Inc. (Cowansville, CA). The FDA issued a Cleared decision on May 31, 2022, 425 days after receiving the submission on April 1, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K210987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2021 |
| Decision Date | May 31, 2022 |
| Days to Decision | 425 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 |