Xylos Xcell Antimicrobial Dressing
FDA 510(k) K024054 · Xylos Corporation
510(k) numberK024054
Submission
- Device name
- Xylos Xcell Antimicrobial Dressing
- Applicant
- Xylos Corporation
Washington, DC, US - Received
- December 9, 2002
- Decision date
- March 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device class
- Unclassified
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| K024367 | Sinclair Wound and Skin EmulsionMGQ · Traditional | Sinclair Pharmaceuticals, Ltd. | 07/28/2003SE |
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| K090880 | Xylos Porous Surgical MeshFTM · Special | 05/27/2009SE |
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| K083823 | Securian Tissue Reinforcement MatrixFTM · Traditional | 03/18/2009SE |
| K081882 | Modification to Xylos Surgical MeshFTM · Special | 07/11/2008SE |
| K023237 | Xylos Surgical MeshFTM · Traditional | 03/18/2003SE |
| K974251 | X-Cell Wound DressingMGQ · Traditional | 06/22/1998SE |
Questions and answers
When was Xylos Xcell Antimicrobial Dressing cleared by the FDA?
Xylos Xcell Antimicrobial Dressing (K024054) received a 510(k) decision of Substantially Equivalent on March 7, 2003, 88 days after the submission was received.
What is the product code of K024054?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.