X-Cell Wound Dressing
FDA 510(k) K974251 · Xylos Corporation
510(k) numberK974251
Submission
- Device name
- X-Cell Wound Dressing
- Applicant
- Xylos Corporation
East Burnswick, NJ, US - Received
- November 13, 1997
- Decision date
- June 22, 1998
- 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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| K041342 | Impruv A.I. Cream Wound and Skin EmulsionMGQ · Traditional | Stiefel Laboratories, Inc. | 07/19/2005SE |
| K041268 | Silversite or CalgitrolMGQ · Traditional | Adri | 09/20/2004SE |
| K040019 | SilversealMGQ · Traditional | Noble Fiber Technologies | 07/23/2004SE |
| K040517 | Tenderwet ActiveMGQ · Traditional | Medline Industries, Inc. | 03/25/2004SE |
| K022587 | Medtrade Product's Antiseptic Barrier Hydrogel DressingsMGQ · Traditional | Medtrade Products , Ltd. | 08/22/2003SE |
| K024367 | Sinclair Wound and Skin EmulsionMGQ · Traditional | Sinclair Pharmaceuticals, Ltd. | 07/28/2003SE |
| K024054 | Xylos Xcell Antimicrobial DressingMGQ · Traditional | Xylos Corporation | 03/07/2003SE |
| K022584 | Cardiotech Antibotic Hydrogel Wound DressingMGQ · Traditional | Cardiotech Intl. | 12/30/2002SE |
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| K023237 | Xylos Surgical MeshFTM · Traditional | 03/18/2003SE |
| K024054 | Xylos Xcell Antimicrobial DressingMGQ · Traditional | 03/07/2003SE |
Questions and answers
When was X-Cell Wound Dressing cleared by the FDA?
X-Cell Wound Dressing (K974251) received a 510(k) decision of Substantially Equivalent on June 22, 1998, 221 days after the submission was received.
What is the product code of K974251?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.