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

    AMT Low-Profile Suprapubic Catheter & Drainage Set

    K Number: K240514 · Decision Nov 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    31
    Applicant Total
    25
    Review Days
    253

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    Basic Information

    Device Name
    AMT Low-Profile Suprapubic Catheter & Drainage Set
    K Number
    K240514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Medical Technology, Inc.
    Date Received
    February 22, 2024
    Decision Date
    November 1, 2024
    Product Code
    KOB
    Advisory Committee
    Gastroenterology, Urology
    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
    KOB Catheter, Suprapubic (And Accessories)

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