Brennen Medical Silver Glucan Wound Dressing
FDA 510(k) K050086 · Brennen Medical, Inc.
510(k) numberK050086
Submission
- Device name
- Brennen Medical Silver Glucan Wound Dressing
- Applicant
- Brennen Medical, Inc.
St. Paul, MN, US - Received
- January 13, 2005
- Decision date
- February 17, 2006
- 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 |
|---|---|---|
| K113866 | Porcine Dermal Xenografts Porcine Dermal MatrixKGN · Traditional | 03/23/2012SE |
| K111436 | Porcine Surgical Mesh, Porcine Dermal MatrixFTM · Traditional | 10/14/2011SE |
| K081272 | Porcine Surgical Mesh; Dermal MatrixFTM · Traditional | 07/31/2008SE |
| K030460 | Modification to Brennen Biosynthetic Surgical Mesh MatrixPAG · Special | 03/07/2003SE |
| K021835 | Brennen Medical Surgical Mesh, Glucamesh/GlucatexFTL · Traditional | 10/17/2002SE |
| K002078 | Beta Glucan Gel (Macropro Gel)MGQ · Traditional | 10/02/2000SE |
| K002077 | Glucanpro CreamMGQ · Traditional | 10/02/2000SE |
| K000519 | GlucanproMGQ · Traditional | 05/01/2000SE |
| K000518 | Macropro GelMGQ · Traditional | 05/01/2000SE |
| K982825 | Brennen Medical Beta Glucan GelMGQ · Traditional | 11/06/1998SE |
Questions and answers
When was Brennen Medical Silver Glucan Wound Dressing cleared by the FDA?
Brennen Medical Silver Glucan Wound Dressing (K050086) received a 510(k) decision of Substantially Equivalent on February 17, 2006, 400 days after the submission was received.
What is the product code of K050086?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.