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

    GMD UNIVERSAL URINARY INCONTINENCE SLING

    K Number: K111219 · Decision Jun 30, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    4
    Review Days
    59

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    Basic Information

    Device Name
    GMD UNIVERSAL URINARY INCONTINENCE SLING
    K Number
    K111219
    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
    Generic Medical Device, Inc.
    Date Received
    May 2, 2011
    Decision Date
    June 30, 2011
    Product Code
    OTN
    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
    OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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    Other Clearances by Generic Medical Device, Inc.

    K Number Device Name
    K083471 GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
    K070018 UNIVERSAL SURGICAL MESH, MODEL 100
    K063429 GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200