K221532 is an FDA 510(k) clearance for the PHMB Wound Dressing. This device is classified as a Dressing, Wound, Drug.
Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 30, 2023, 249 days after receiving the submission on May 26, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K221532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2022 |
| Decision Date | January 30, 2023 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |