Calgitrol AG Silver Alginate Wound Dressing
FDA 510(k) K011618 · Adri
510(k) numberK011618
Submission
- Device name
- Calgitrol AG Silver Alginate Wound Dressing
- Applicant
- Adri
Park Forest, IL, US - Received
- May 25, 2001
- Decision date
- November 15, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K041268 | Silversite or CalgitrolMGQ · Traditional | 09/20/2004SE |
| K000054 | Foam Calcium Alginate Topical Wound Dressing with CollagenKGN · Traditional | 03/13/2000SE |
| K963656 | Foam Calcium Aliginate Topical Wound DressingKMF · Traditional | 11/12/1996SE |
| K940404 | Alginate Fiber Topical Wound DressingKMF · Traditional | 05/04/1994SN |
| K870383 | Alginate Wool FiberKHR · Traditional | 04/30/1987SE |
Questions and answers
When was Calgitrol AG Silver Alginate Wound Dressing cleared by the FDA?
Calgitrol AG Silver Alginate Wound Dressing (K011618) received a 510(k) decision of Substantially Equivalent on November 15, 2002, 539 days after the submission was received.
What is the product code of K011618?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.