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

    EvoEndo Single-Use Endoscopy System

    K Number: K250900 · Decision Jun 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    74
    Applicant Total
    4
    Review Days
    83

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    Basic Information

    Device Name
    EvoEndo Single-Use Endoscopy System
    K Number
    K250900
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    EvoEndo, Inc.
    Date Received
    March 25, 2025
    Decision Date
    June 16, 2025
    Product Code
    FDS
    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
    FDS Gastroscope And Accessories, Flexible/Rigid

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    Other Clearances by EvoEndo, Inc.

    K Number Device Name
    K260573 EvoEndo Single-Use Endoscopy System
    K251708 EvoEndo Single-Use Endoscopy System
    K213606 EvoEndo Single-Use Endoscopy System