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

    ArcSP Suprapubic Sling System

    K Number: K222293 · Decision Sep 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    3
    Review Days
    51

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    Basic Information

    Device Name
    ArcSP Suprapubic Sling System
    K Number
    K222293
    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 1, 2022
    Decision Date
    September 21, 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
    K222468 ArcTO Transobturator Sling System
    K183134 ArcTV Transvaginal Sling System