Microcyn Antimicrobial Hydrogel
FDA 510(k) K173896 · Sonoma Pharmaceuticals, Inc.
510(k) numberK173896
Submission
- Device name
- Microcyn Antimicrobial Hydrogel
- Applicant
- Sonoma Pharmaceuticals, Inc.
Petaluma, CA, US - Received
- December 22, 2017
- Decision date
- April 2, 2018
- 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 |
| 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 |
| K240510 | Microdacyn HydrogelFRO · Traditional | 11/08/2024SE |
| K233399 | Microdacyn Wound Care SolutionFRO · Traditional | 09/13/2024SE |
| 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 Microcyn Antimicrobial Hydrogel cleared by the FDA?
Microcyn Antimicrobial Hydrogel (K173896) received a 510(k) decision of Substantially Equivalent on April 2, 2018, 101 days after the submission was received.
What is the product code of K173896?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.