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

    Ancora-SB

    K Number: K260314 · Decision May 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    91

    Basic Information

    Device Name
    Ancora-SB
    K Number
    K260314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aspero Medical, Inc.
    Date Received
    January 30, 2026
    Decision Date
    May 1, 2026
    Product Code
    FDA
    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
    FDA Enteroscope And Accessories

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    Other Clearances by Aspero Medical, Inc.

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