K251567
- 510(k) number
- K251567
- Device name
- NovoSorb BTM
- Applicant
- Polynovo Biomaterials Pty, Ltd. AU
- Product code
- QSZ — Absorbable Synthetic Wound Dressing
- Decision date
- 2025-06-20
- Date received
- 2025-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251567.pdf
Official FDA record: K251567
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.