FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SiOxD Wound Matrix
K Number: K222189
·
Decision Nov 18, 2022
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
18
Applicant Total
5
Review Days
119
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SiOxD Wound Matrix
- K Number
- K222189
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sioxmed, LLC
- Date Received
- July 22, 2022
- Decision Date
- November 18, 2022
- 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.
Redermo Wound Matrix
FDA 510(k)
FDA Unclassified
·Unknown
NovoSorb BTM
FDA 510(k)
FDA Unclassified
·Unknown
NovoSorb® MTX
FDA 510(k)
FDA Unclassified
·Unknown
SiOxD® Wound Matrix
FDA 510(k)
FDA Unclassified
·Unknown
SiOxD Wound Matrix
FDA 510(k)
FDA Unclassified
·Unknown
Restrata® MiniMatrix
FDA 510(k)
FDA Unclassified
·Unknown