K251567 is an FDA 510(k) clearance for the NovoSorb BTM. This device is classified as a Absorbable Synthetic Wound Dressing.
Submitted by Polynovo Biomaterials Pty, Ltd. (Melbourne, AU). The FDA issued a Cleared decision on June 20, 2025, 29 days after receiving the submission on May 22, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application..
| 510(k) Number | K251567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2025 |
| Decision Date | June 20, 2025 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSZ - Absorbable Synthetic Wound Dressing |
| Device Class | - |
| Definition | Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application. |