Collagen-Orc Antimicrobial Matrix
FDA 510(k) K033523 · Johnson & Johnson Medical, Ltd.
510(k) numberK033523
Submission
- Device name
- Collagen-Orc Antimicrobial Matrix
- Applicant
- Johnson & Johnson Medical, Ltd.
Somerville, NJ, US - Received
- November 7, 2003
- Decision date
- October 21, 2004
- 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
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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 |
|---|---|---|
| K022483 | Actisorb Silver 220 Antimicrobial Binding DressingFRO · Traditional | 02/03/2003SE |
| K014129 | Promogran Matrix Wound DressingKGN · Traditional | 02/14/2002SE |
| K001690 | Protectiv Safety Blood Collection NeedleFMI · Traditional | 07/31/2000SE |
| K982641 | Advanced Nibp ModuleDXN · Traditional | 03/29/1999SE |
| K983362 | Nu-Gel * Wound DressingMGQ · Traditional | 12/16/1998SE |
| K982597 | Fibrcol Plus Collagen Wound Dressing with AlginateKGN · Traditional | 08/20/1998SE |
| K974080 | Critikon Soft Blood Pressure CuffDXQ · Traditional | 05/18/1998SE |
| K980493 | I.V. Catheter SystemFOZ · Traditional | 04/28/1998SE |
| K972498 | Observer * Central StationDSI · Traditional | 02/17/1998SE |
| K973699 | Ultralon Powder Free Latex Surgical GloveKGO · Traditional | 12/16/1997SE |
Questions and answers
When was Collagen-Orc Antimicrobial Matrix cleared by the FDA?
Collagen-Orc Antimicrobial Matrix (K033523) received a 510(k) decision of Substantially Equivalent on October 21, 2004, 349 days after the submission was received.
What is the product code of K033523?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.