BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    Rusch SoftSimplastic Foley Catheters

    K Number: K252537 · Decision Jan 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    2
    Review Days
    161

    Basic Information

    Device Name
    Rusch SoftSimplastic Foley Catheters
    K Number
    K252537
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teleflex Medical Sdn. Bhd.
    Date Received
    August 12, 2025
    Decision Date
    January 20, 2026
    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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