Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
FDA 510(k) K202982 · Winner Medical Co., Ltd.
510(k) numberK202982
Submission
- Device name
- Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
- Applicant
- Winner Medical Co., Ltd.
Shenzhen, CN - Received
- September 30, 2020
- Decision date
- October 19, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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|---|---|---|---|
| K254041 | SkinSmart Antimicrobial HydroGelFRO · Traditional | Magic Science Supply, LLC | 09/11/2026SE |
| K261646 | Redermax® Antibacterial Wound MatrixFRO · Traditional | Beijing Kreate Medical Co., Ltd. | 08/14/2026SE |
| K253665 | Vashe Plus Antimicrobial SolutionFRO · Traditional | Urgo Medical North America, LLC | 08/11/2026SE |
| K261023 | Microdacyn Wound Irrigation SolutionFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 06/24/2026SE |
| K251929 | SilverCeuticals® Antimicrobial Wound GelFRO · Traditional | Silverceuticals, Inc. | 06/24/2026SE |
| K261638 | Bonvadis®FRO · Special | Oneness Biotech Co., Ltd. | 06/17/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | Merit Medical Systems, Inc. | 05/13/2026SE |
| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
| K251999 | Promogran Prisma Collagen Matrix with ORC and SilverFRO · Traditional | Solventum Germany GmbH | 03/13/2026SE |
More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K252001 | Collagen Wound DressingKGN · Traditional | 10/10/2025SE |
| K250082 | Procedure mask/Surgical mask/Face maskFXX · Traditional | 06/18/2025SE |
| K231057 | Antibacterial Gel Wound DressingFRO · Traditional | 12/01/2023SE |
| K231564 | Skin and Wound CleanserFRO · Traditional | 11/10/2023SE |
| K231152 | Collagen Wound DressingKGN · Traditional | 10/12/2023SE |
| K221311 | Antibacterial BandageFRO · Traditional | 06/21/2023SE |
| K223232 | Procedure mask/Surgical mask/Face maskFXX · Traditional | 03/06/2023SE |
| K221532 | PHMB Wound DressingFRO · Traditional | 01/30/2023SE |
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…FRO · Special | 01/17/2023SE |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…FRO · Special | 01/13/2023SE |
Questions and answers
When was Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) cleared by the FDA?
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) (K202982) received a 510(k) decision of Substantially Equivalent on October 19, 2021, 384 days after the submission was received.
What is the product code of K202982?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.