PHMB Antimicrobial Foam Wound Dressing
FDA 510(k) K163062 · Advanced Medical Solutions, Ltd.
510(k) numberK163062
Submission
- Device name
- PHMB Antimicrobial Foam Wound Dressing
- Applicant
- Advanced Medical Solutions, Ltd.
Winsford, GB - Received
- November 2, 2016
- Decision date
- July 25, 2017
- 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 |
|---|---|---|
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMBFRO · Traditional | 10/26/2023SE |
| K223310 | Antimicrobial Silicone PHMB Foam Wound DressingFRO · Special | 04/05/2023SE |
| K211878 | LiquiBand XLOMD · Traditional | 05/23/2022SE |
| K210974 | High Performance Antimicrobial Gelling Fiber with SilverFRO · Special | 05/12/2021SE |
| K183570 | LiquiBand PlusMPN · Traditional | 03/09/2020SE |
| K190819 | Silicone PHMB Foam Wound DressingFRO · Traditional | 07/25/2019SE |
| K183645 | Silver High Performance DressingFRO · Traditional | 05/29/2019SE |
| K180634 | Surgical Silver Post Operative DressingFRO · Traditional | 08/07/2018SE |
| K181197 | PHMB Foam Wound DressingFRO · Traditional | 08/03/2018SE |
| K110458 | Silver Antimicrobial Wound GelFRO · Special | 03/14/2011SE |
Questions and answers
When was PHMB Antimicrobial Foam Wound Dressing cleared by the FDA?
PHMB Antimicrobial Foam Wound Dressing (K163062) received a 510(k) decision of Substantially Equivalent on July 25, 2017, 265 days after the submission was received.
What is the product code of K163062?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.