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

    DESARA MINI

    K Number: K103418 · Decision Nov 30, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    19
    Applicant Total
    22
    Review Days
    373

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    Basic Information

    Device Name
    DESARA MINI
    K Number
    K103418
    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
    Caldera Medical, Inc.
    Date Received
    November 22, 2010
    Decision Date
    November 30, 2011
    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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    Other Clearances by Caldera Medical, Inc.

    K Number Device Name
    K233500 Benesta Tissue Removal Device
    K211975 Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
    K192811 BenestaTM Tissue Removal Device
    K192822 Benesta Hysteroscope
    K193603 Benesta Medical Sterilization Tray
    K191416 Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
    K172614 Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left
    K162201 Desara TV, Desara Blue TV
    K150016 Vertessa Lite
    K150023 Vertessa Lite Y-Mesh
    Search all 22 clearances from Caldera Medical, Inc. →