FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
Collagen Wound Dressing
K Number: K252001
·
Decision Oct 10, 2025
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
18
Review Days
105
Basic Information
- Device Name
- Collagen Wound Dressing
- K Number
- K252001
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Winner Medical Co., Ltd.
- Date Received
- June 27, 2025
- Decision Date
- October 10, 2025
- Product Code
- KGN
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGN), ordered by most recent decision date.
ECMT-100 WMD
FDA 510(k)
FDA Unclassified
·Unknown
Catalyze
FDA 510(k)
FDA Unclassified
·Unknown
Roosin Collagen Dressing
FDA 510(k)
FDA Unclassified
·Unknown
Roosin Collagen Powder
FDA 510(k)
FDA Unclassified
·Unknown
MatriDerm
FDA 510(k)
FDA Unclassified
·Unknown
Derma-Gide
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Winner Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250082 | Procedure mask/Surgical mask/Face mask | Jun 18, 2025 | Substantially Equivalent |
| K231057 | Antibacterial Gel Wound Dressing | Dec 1, 2023 | Substantially Equivalent |
| K231564 | Skin and Wound Cleanser | Nov 10, 2023 | Substantially Equivalent |
| K231152 | Collagen Wound Dressing | Oct 12, 2023 | Substantially Equivalent |
| K221311 | Antibacterial Bandage | Jun 21, 2023 | Substantially Equivalent |
| K223232 | Procedure mask/Surgical mask/Face mask | Mar 6, 2023 | Substantially Equivalent |
| K221532 | PHMB Wound Dressing | Jan 30, 2023 | Substantially Equivalent |
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) | Jan 17, 2023 | Substantially Equivalent |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing | Jan 13, 2023 | Substantially Equivalent |
| K221720 | Extra Silver Gelling Fiber Dressing | Dec 21, 2022 | Substantially Equivalent |