BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AVANCE® FOAM ABDOMINAL DRESSING KIT

    K Number: K130852 · Decision Apr 14, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    1
    Applicant Total
    9
    Review Days
    382

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    Basic Information

    Device Name
    AVANCE® FOAM ABDOMINAL DRESSING KIT
    K Number
    K130852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Molnlycke Health Care
    Date Received
    March 28, 2013
    Decision Date
    April 14, 2014
    Product Code
    OXJ
    Advisory Committee
    General, Plastic Surgery
    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
    OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OXJ), ordered by most recent decision date.

    Avance Abdominal Dressing Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
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    Other Clearances by Molnlycke Health Care

    K Number Device Name
    K130040 MEPITEL AG
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    K122132 AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
    K102923 BARRIER N95 PARTICULATE RESPIRATOR
    K100029 MEPILEX BORDER AG DRESSING
    K061554 MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
    K050786 BARRIER SURGICAL GOWNS
    K031131 KLINIDRAPE SURGICAL DRAPES