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

    ALTIS SINGLE INCISION CLING SYSTEM

    K Number: K121562 · Decision Nov 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    19
    Applicant Total
    71
    Review Days
    160

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    Basic Information

    Device Name
    ALTIS SINGLE INCISION CLING SYSTEM
    K Number
    K121562
    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
    Coloplast A/S
    Date Received
    May 29, 2012
    Decision Date
    November 5, 2012
    Product Code
    PAH
    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
    PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

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    K140523 RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
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