FDA 510(k)
FDA unclassified
Substantially Equivalent
🇦🇺 Australia
NovoSorb® MTX
K Number: K242149
·
Decision Mar 5, 2025
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
12
Applicant Total
4
Review Days
225
Basic Information
- Device Name
- NovoSorb® MTX
- K Number
- K242149
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PolyNovo Biomaterials Pty Ltd
- Date Received
- July 23, 2024
- Decision Date
- March 5, 2025
- Product Code
- QSZ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QSZ | Absorbable Synthetic Wound Dressing | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QSZ), ordered by most recent decision date.
NovoSorb BTM
FDA 510(k)
FDA Unclassified
·Unknown
NovoSorb Matrix
FDA 510(k)
FDA Unclassified
·Unknown
Restrata®
FDA 510(k)
FDA Unclassified
·Unknown
Phoenix Wound Matrix
FDA 510(k)
FDA Unclassified
·Unknown
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)
FDA 510(k)
FDA Unclassified
·Unknown
SupraSDRM Biodegradable Matrix Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by PolyNovo Biomaterials Pty Ltd
| K Number | Device Name | ||
|---|---|---|---|
| K251567 | NovoSorb BTM | Jun 20, 2025 | Substantially Equivalent |
| K221686 | NovoSorb Matrix | Sep 15, 2022 | Substantially Equivalent |
| K172140 | 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) | Aug 11, 2017 | Substantially Equivalent |