Extra Silver Gelling Fiber Dressing
FDA 510(k) K221720 · Winner Medical Co., Ltd.
510(k) numberK221720
Submission
- Device name
- Extra Silver Gelling Fiber Dressing
- Applicant
- Winner Medical Co., Ltd.
Shenzhen, CN - Received
- June 13, 2022
- Decision date
- December 21, 2022
- 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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| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
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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 Extra Silver Gelling Fiber Dressing cleared by the FDA?
Extra Silver Gelling Fiber Dressing (K221720) received a 510(k) decision of Substantially Equivalent on December 21, 2022, 191 days after the submission was received.
What is the product code of K221720?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.