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

    EndoSound Vision System; EVS

    K Number: K232518 · Decision Dec 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    42
    Applicant Total
    2
    Review Days
    131

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    Basic Information

    Device Name
    EndoSound Vision System; EVS
    K Number
    K232518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endosound, Inc.
    Date Received
    August 18, 2023
    Decision Date
    December 27, 2023
    Product Code
    ODG
    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
    ODG Endoscopic Ultrasound System, Gastroenterology-Urology

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    Other Clearances by Endosound, Inc.

    K Number Device Name
    K250145 Biopsy Port Adapter