FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)
K Number: K221754
·
Decision Jan 17, 2023
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
18
Review Days
215
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
- Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)
- K Number
- K221754
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Winner Medical Co., Ltd.
- Date Received
- June 16, 2022
- Decision Date
- January 17, 2023
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRO), ordered by most recent decision date.
Bonvadis®
FDA 510(k)
FDA Unclassified
·Unknown
StatSeal Disc
FDA 510(k)
FDA Unclassified
·Unknown
IWD-Gel
FDA 510(k)
FDA Unclassified
·Unknown
MiraChlor Antimicrobial Wound Solution
FDA 510(k)
FDA Unclassified
·Unknown
Promogran Prisma Collagen Matrix with ORC and Silver
FDA 510(k)
FDA Unclassified
·Unknown
LUOFUCON® Antimicrobial Wound Gel
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Winner Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252001 | Collagen Wound Dressing | Oct 10, 2025 | Substantially Equivalent |
| 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 |
| 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 |