K203446 is an FDA 510(k) clearance for the TorrentX Wound Wash. This device is classified as a Dressing, Wound, Drug.
Submitted by Next Science, LLC (Jacksonsonville, US). The FDA issued a Cleared decision on September 23, 2021, 304 days after receiving the submission on November 23, 2020.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K203446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2020 |
| Decision Date | September 23, 2021 |
| Days to Decision | 304 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |