Atraum Wound Dressing
FDA 510(k) K852614 · Axiom Medical, Inc.
510(k) numberK852614
Submission
- Device name
- Atraum Wound Dressing
- Applicant
- Axiom Medical, Inc.
Paramount, CA, US - Received
- June 20, 1985
- Decision date
- August 30, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K993592 | Axiom Multipurpose Wound DrainBSO · Traditional | 05/17/2000SE |
| K971851 | Interpleural Anesthesia CatheterBSO · Traditional | 01/22/1998SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | 03/10/1997SE |
| K934895 | Glassman Silicone CatheterEZL · Traditional | 10/13/1994SE |
| K922760 | Atraum Wound Dressing--ModificationKMF · Traditional | 10/30/1992SE |
| K905422 | PVC Round Wound DrainsGBX · Traditional | 02/11/1991SE |
| K904218 | Suction SystemGEA · Traditional | 10/31/1990SE |
| K904133 | Disposable Fluid Collection BagGBX · Traditional | 10/11/1990SE |
| K863247 | Axiom Trocar Thoracic CatheterGBS · Traditional | 08/29/1986SE |
| K861306 | Suction SystemGEA · Traditional | 06/09/1986SE |
Questions and answers
When was Atraum Wound Dressing cleared by the FDA?
Atraum Wound Dressing (K852614) received a 510(k) decision of Substantially Equivalent on August 30, 1985, 71 days after the submission was received.
What is the product code of K852614?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.