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

    2-Way 100% Silicone ClearTract Catheter

    K Number: K221625 · Decision Jul 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    2
    Review Days
    25

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    Basic Information

    Device Name
    2-Way 100% Silicone ClearTract Catheter
    K Number
    K221625
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Silq Technologies Corporation
    Date Received
    June 6, 2022
    Decision Date
    July 1, 2022
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

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    Other Clearances by Silq Technologies Corporation

    K Number Device Name
    K233013 2-Way 100% Silicone Cleartract Catheter