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

    ArcTO Transobturator Sling System

    K Number: K222468 · Decision Sep 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    3
    Review Days
    30

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    Basic Information

    Device Name
    ArcTO Transobturator Sling System
    K Number
    K222468
    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
    Urocure, LLC
    Date Received
    August 16, 2022
    Decision Date
    September 15, 2022
    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 Urocure, LLC

    K Number Device Name
    K222293 ArcSP Suprapubic Sling System
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