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

    AMCATH DISPOSABLE BIOPSY FORCEPS

    K Number: K915142 · Decision Jan 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    17
    Review Days
    57

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    Basic Information

    Device Name
    AMCATH DISPOSABLE BIOPSY FORCEPS
    K Number
    K915142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intl. Medical, Inc.
    Date Received
    November 14, 1991
    Decision Date
    January 10, 1992
    Product Code
    FCF
    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
    FCF Instrument, Biopsy, Mechanical, Gastrointestinal

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