BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS

    K Number: K042659 · Decision Feb 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    139

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    Basic Information

    Device Name
    MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
    K Number
    K042659
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medisiss
    Date Received
    September 28, 2004
    Decision Date
    February 14, 2005
    Product Code
    NON
    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
    NON Forceps, Biopsy, Non-Electric, Reprocessed

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