BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    X-CELL WOUND DRESSING

    K Number: K974251 · Decision Jun 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    9
    Review Days
    221

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    Basic Information

    Device Name
    X-CELL WOUND DRESSING
    K Number
    K974251
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xylos Corporation
    Date Received
    November 13, 1997
    Decision Date
    June 22, 1998
    Product Code
    MGQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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    Other Clearances by Xylos Corporation

    K Number Device Name
    K111584 XYLOS MACRO-POROUS SURGICAL MESH
    K100984 XYLOS VESSEL GUARD
    K090880 XYLOS POROUS SURGICAL MESH
    K090778 MTA PROTECTIVE SHEET
    K083823 SECURIAN TISSUE REINFORCEMENT MATRIX
    K081882 MODIFICATION TO XYLOS SURGICAL MESH
    K023237 XYLOS SURGICAL MESH
    K024054 XYLOS XCELL ANTIMICROBIAL DRESSING