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

    ExpressCore Biopsy Device

    K Number: K243886 · Decision Apr 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    4
    Review Days
    132

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    Basic Information

    Device Name
    ExpressCore Biopsy Device
    K Number
    K243886
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inrad, Inc.
    Date Received
    December 18, 2024
    Decision Date
    April 29, 2025
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNW Instrument, Biopsy

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    Other Clearances by Inrad, Inc.

    K Number Device Name
    K240429 Trilogy Tissue Marker
    K183503 EasyMark Tissue Marker
    K112945 ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM