BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    OMNISURE URETHRAL SLING, MODEL OTK52

    K Number: K092203 · Decision Aug 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    OMNISURE URETHRAL SLING, MODEL OTK52
    K Number
    K092203
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mpathy Medical Devices, Ltd.
    Date Received
    July 22, 2009
    Decision Date
    August 12, 2009
    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 Mpathy Medical Devices, Ltd.

    K Number Device Name
    K091180 MINITAPE URETHRAL SLING
    K073647 MINITAPE EXTRA URETHRAL SLING
    K073646 MINITAPE URETHRAL SLING
    K053361 MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
    K041632 MINIMESH POLYPROPYLENE MESH