IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver
FDA 510(k) K112549 · Covalontechnologies, Inc.
510(k) numberK112549
Submission
- Device name
- IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver
- Applicant
- Covalontechnologies, Inc.
Mississauga, Ontario, CA - Received
- September 1, 2011
- Decision date
- May 4, 2012
- 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
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| K253665 | Vashe Plus Antimicrobial SolutionFRO · Traditional | Urgo Medical North America, LLC | 08/11/2026SE |
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| 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 |
|---|---|---|
| K163556 | MediClear PreOpKKX · Traditional | 09/14/2017SE |
| K150550 | SilverCoat Silicone Foley CatheterEZL · Traditional | 11/24/2015SE |
| K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverFRO · Traditional | 08/13/2012SE |
| K043296 | Colactive AG Collagen with Silver Antimicrobial DressingFRO · Traditional | 06/06/2005SE |
| K050177 | Colactive Collagen Wound DressingKGN · Traditional | 04/27/2005SE |
Questions and answers
When was IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver cleared by the FDA?
IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver (K112549) received a 510(k) decision of Substantially Equivalent on May 4, 2012, 246 days after the submission was received.
What is the product code of K112549?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.