MIS Solution
FDA 510(k) K203835 · Next Science, LLC
510(k) numberK203835
Submission
- Device name
- MIS Solution
- Applicant
- Next Science, LLC
Jacksonsonville, FL, US - Received
- December 30, 2020
- Decision date
- April 23, 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 |
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| 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 |
|---|---|---|
| K203446 | TorrentX Wound WashFRO · Traditional | 09/23/2021SE |
| K192349 | Bactisure Wound LavageFQH · Traditional | 01/23/2020SE |
| K163188 | Next Science Wound Gel (Rx)FRO · Traditional | 03/06/2017SE |
| K161165 | Next Science Irrigation SolutionFQH · Traditional | 09/07/2016SE |
| K150792 | Next Science Wound GelFRO · Traditional | 12/17/2015SE |
Questions and answers
When was MIS Solution cleared by the FDA?
MIS Solution (K203835) received a 510(k) decision of Substantially Equivalent on April 23, 2021, 114 days after the submission was received.
What is the product code of K203835?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.