Silverlon Wound Contact, Burn Contact Dressings
FDA 510(k) K221218 · Argentum Medical, Inc.
510(k) numberK221218
Submission
- Device name
- Silverlon Wound Contact, Burn Contact Dressings
- Applicant
- Argentum Medical, Inc.
Geneva, IL, US - Received
- April 27, 2022
- Decision date
- October 26, 2022
- 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 |
|---|---|---|
| K241225 | Silverlon® Wound Contact, Burn Contact DressingFRO · Traditional | 07/31/2024SE |
| K190343 | Silverlon Wound Contact, Burn Contact DressingsFRO · Traditional | 07/18/2019SE |
| K180570 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon…FRO · Traditional | 01/14/2019SE |
| K150256 | Silverlon Burn Contact DressingsFRO · Traditional | 04/30/2015SE |
| K143001 | Silverlon Island Wound Dressing, Silverlon Wound Pad DressingFRO · Special | 11/07/2014SE |
| K141033 | Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…OMP · Traditional | 09/12/2014SE |
| K141573 | Silverlon Island Wound DressingFRO · Special | 08/28/2014SE |
| K122817 | Silverlon Island Wound DressingFRO · Traditional | 05/01/2014SE |
| K053590 | Silverlon Ca (Calcium Alginate)FRO · Traditional | 10/06/2006SE |
Questions and answers
When was Silverlon Wound Contact, Burn Contact Dressings cleared by the FDA?
Silverlon Wound Contact, Burn Contact Dressings (K221218) received a 510(k) decision of Substantially Equivalent on October 26, 2022, 182 days after the submission was received.
What is the product code of K221218?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.