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

    STRATASIS SLING KIT

    K Number: K020654 · Decision Apr 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    8
    Applicant Total
    31
    Review Days
    40

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    Basic Information

    Device Name
    STRATASIS SLING KIT
    K Number
    K020654
    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
    Cook Biotech, Inc.
    Date Received
    February 28, 2002
    Decision Date
    April 9, 2002
    Product Code
    PAG
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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    Other Clearances by Cook Biotech, Inc.

    K Number Device Name
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    K111695 HYBRID GRAFT
    K110402 BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
    K090688 COOK UROLOGICAL GRAFT
    K082682 SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
    K082058 DYNAMATRIX
    K073391 SURGISIS BIODESIGN TISSUE GRAFT
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    Search all 31 clearances from Cook Biotech, Inc. →