NovoSorb BTM
FDA 510(k) clearance K251567 · decided 2025-06-20
Clearance details
- K-number
- K251567
- Device name
- NovoSorb BTM
- Applicant
- Polynovo Biomaterials Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-22
- Decision date
- 2025-06-20
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- QSZ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Melbourne, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Redermo Wound Matrix (K260020) | Beijing Kreate Medical Co., Ltd. | 2026-04-16 |
| NovoSorb® MTX (K242149) | Polynovo Biomaterials Pty, Ltd. | 2025-03-05 |
| SiOxD® Wound Matrix (K241660) | Sioxmed, LLC | 2024-07-05 |
| SiOxD Wound Matrix (K232847) | Sioxmed, LLC | 2023-12-18 |
| Restrata® MiniMatrix (K223725) | Acera Surgical, Inc. | 2023-05-18 |
| SiOxD Wound Matrix (K222189) | Sioxmed, LLC | 2022-11-18 |
| NovoSorb Matrix (K221686) | Polynovo Biomaterials Pty, Ltd. | 2022-09-15 |
| Restrata® (K193583) | Acera Surgical, Inc. | 2020-09-25 |
| Phoenix Wound Matrix (K173544) | Nanofiber Solutions, Inc. | 2018-03-02 |
| NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (K172140) | Polynovo Biomaterials Pty, Ltd. | 2017-08-11 |
| SupraSDRM Biodegradable Matrix Wound Dressing (K170213) | Polymedics Innovations, GmbH | 2017-06-28 |
| Restrata Wound Matrix (K170300) | Acera Surgical, Inc. | 2017-04-26 |
Recalls involving this device
No recalls on record reference this clearance.