LT Antibacterial Alginate with Silver Dressing
FDA 510(k) K192478 · Zhejiang Longterm Medical Technology Co., Ltd.
510(k) numberK192478
Submission
- Device name
- LT Antibacterial Alginate with Silver Dressing
- Applicant
- Zhejiang Longterm Medical Technology Co., Ltd.
Deqing, CN - Received
- September 10, 2019
- Decision date
- June 17, 2020
- 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 |
|---|---|---|
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | 09/10/2026SE |
| K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitOMP · Traditional | 05/31/2022SE |
| K202823 | Innomed NPWT Silicone Foam DressingOMP · Traditional | 12/15/2021SE |
| K182458 | Longterm NPWT Foam Dressing KitOMP · Traditional | 05/23/2019SE |
Questions and answers
When was LT Antibacterial Alginate with Silver Dressing cleared by the FDA?
LT Antibacterial Alginate with Silver Dressing (K192478) received a 510(k) decision of Substantially Equivalent on June 17, 2020, 281 days after the submission was received.
What is the product code of K192478?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.