Fortaderm Antimicrobial Wound Dressing
FDA 510(k) K051647 · Organogenesis, Inc.
510(k) numberK051647
Submission
- Device name
- Fortaderm Antimicrobial Wound Dressing
- Applicant
- Organogenesis, Inc.
Canton, MA, US - Received
- June 21, 2005
- Decision date
- November 8, 2005
- 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 |
|---|---|---|
| K212579 | FortiShield (Biosynthetic Wound Matrix)KGN · Traditional | 05/02/2023SE |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ)KGN · Traditional | 07/01/2022SE |
| K071555 | Fortagen Oral MembraneNPL · Traditional | 08/30/2007SE |
| K042809 | CuffpatchFTM · Traditional | 11/02/2004SE |
| K021107 | Fortaflex Surgical SlingFTM · Traditional | 05/15/2002SE |
| K021105 | Fortaflex Surgical MeshFTM · Traditional | 05/10/2002SE |
| K020049 | Fortaflex Surgical MeshFTM · Traditional | 03/18/2002SE |
| K011025 | Fortaflex Surgical MeshFTM · Traditional | 08/24/2001SE |
| K011026 | Fortaderm Wound DressingKGN · Traditional | 06/13/2001SE |
| K011027 | Fortaflex Surgical SlingFTM · Traditional | 05/30/2001SE |
Questions and answers
When was Fortaderm Antimicrobial Wound Dressing cleared by the FDA?
Fortaderm Antimicrobial Wound Dressing (K051647) received a 510(k) decision of Substantially Equivalent on November 8, 2005, 140 days after the submission was received.
What is the product code of K051647?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.