FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SiOxD® Wound Matrix
K Number: K241660
·
Decision Jul 5, 2024
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
18
Applicant Total
5
Review Days
25
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Basic Information
- Device Name
- SiOxD® Wound Matrix
- K Number
- K241660
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sioxmed, LLC
- Date Received
- June 10, 2024
- Decision Date
- July 5, 2024
- 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 |
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