K223310 is an FDA 510(k) clearance for the Antimicrobial Silicone PHMB Foam Wound Dressing. This device is classified as a Dressing, Wound, Drug.
Submitted by Advanced Medical Solutions Limited (Winsford, GB). The FDA issued a Cleared decision on April 5, 2023, 159 days after receiving the submission on October 28, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K223310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2022 |
| Decision Date | April 05, 2023 |
| Days to Decision | 159 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |