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

    CVAC Image Processor

    K Number: K260013 · Decision Mar 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    3
    Review Days
    60

    Basic Information

    Device Name
    CVAC Image Processor
    K Number
    K260013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Calyxo, Inc.
    Date Received
    January 5, 2026
    Decision Date
    March 6, 2026
    Product Code
    FGB
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

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    Other Clearances by Calyxo, Inc.

    K Number Device Name
    K260965 CVAC Aspiration System
    K233472 CVAC Aspiration System + CVAC Image Processor