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

    EASY CORE BIOPSY SYSTEM

    K Number: K040893 · Decision May 6, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    432
    Review Days
    30

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    Basic Information

    Device Name
    EASY CORE BIOPSY SYSTEM
    K Number
    K040893
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    April 6, 2004
    Decision Date
    May 6, 2004
    Product Code
    FCG
    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
    FCG Biopsy Needle

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