K220759 is an FDA 510(k) clearance for the Armis VeriCyn Wound Wash. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Armis Biopharma, Inc. (Fort Collins, US). The FDA issued a Cleared decision on May 25, 2023, 436 days after receiving the submission on March 15, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K220759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2022 |
| Decision Date | May 25, 2023 |
| Days to Decision | 436 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 |