Vashe Plus Antimicrobial Solution
FDA 510(k) K253665 · Urgo Medical North America, LLC
510(k) numberK253665
Submission
- Device name
- Vashe Plus Antimicrobial Solution
- Applicant
- Urgo Medical North America, LLC
Fort Worth, TX, US - Received
- November 21, 2025
- Decision date
- August 11, 2026
- 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
Other 510(k)s with product code FRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K252028 | LUOFUCON® Antimicrobial Wound GelFRO · Traditional | Huizhou Foryou Medical Co., Ltd. | 03/11/2026SE |
Questions and answers
When was Vashe Plus Antimicrobial Solution cleared by the FDA?
Vashe Plus Antimicrobial Solution (K253665) received a 510(k) decision of Substantially Equivalent on August 11, 2026, 263 days after the submission was received.
What is the product code of K253665?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.