510(k) K251567
K251567 is an FDA 510(k) premarket notification submitted by Polynovo Biomaterials Pty, Ltd. for the device "NovoSorb BTM". The FDA issued a decision of Substantially Equivalent on June 20, 2025. The device falls under product code QSZ (Absorbable Synthetic Wound Dressing), a Class U device. Polynovo Biomaterials Pty, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2025
- Date Received
- May 22, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbable Synthetic Wound Dressing
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.