FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
K Number: K252167
·
Decision Dec 19, 2025
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
2
Review Days
162
Basic Information
- Device Name
- Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
- K Number
- K252167
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qingdao Bright Moon Biomedical Materials Co., Ltd.
- Date Received
- July 10, 2025
- Decision Date
- December 19, 2025
- Product Code
- FRO
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Qingdao Bright Moon Biomedical Materials Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K220673 | Sterile Silver Alginate Wound Dressing | Mar 16, 2023 | Substantially Equivalent |