Microdacyn Hydrogel
FDA 510(k) K240510 · Sonoma Pharmaceuticals, Inc.
510(k) numberK240510
Submission
- Device name
- Microdacyn Hydrogel
- Applicant
- Sonoma Pharmaceuticals, Inc.
Petaluma, CA, US - Received
- February 22, 2024
- Decision date
- November 8, 2024
- 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 |
|---|---|---|
| K261023 | Microdacyn Wound Irrigation SolutionFRO · Traditional | 06/24/2026SE |
| K233399 | Microdacyn Wound Care SolutionFRO · Traditional | 09/13/2024SE |
| K173896 | Microcyn Antimicrobial HydrogelFRO · Traditional | 04/02/2018SE |
| K171935 | Alevicyn SG Antimicrobial GelFRO · Traditional | 12/01/2017SE |
| K172622 | Microcyn Antimicrobial Skin and Wound CleanserFRO · Traditional | 11/21/2017SE |
| K172851 | Microcyn Plus Antimicrobial Wound Care SolutionFRO · Traditional | 11/15/2017SE |
| K171727 | Hydrocleanse Antimicrobial Skin and Wound Care SolutionFRO · Traditional | 07/26/2017SE |
Questions and answers
When was Microdacyn Hydrogel cleared by the FDA?
Microdacyn Hydrogel (K240510) received a 510(k) decision of Substantially Equivalent on November 8, 2024, 260 days after the submission was received.
What is the product code of K240510?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.