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

    MODIFICATION TO EN-BLOC BIOPSY SYSTEM

    K Number: K033427 · Decision Nov 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    7
    Review Days
    13

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    Basic Information

    Device Name
    MODIFICATION TO EN-BLOC BIOPSY SYSTEM
    K Number
    K033427
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neothermia Corp.
    Date Received
    October 28, 2003
    Decision Date
    November 10, 2003
    Product Code
    KNW
    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
    KNW Instrument, Biopsy

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    Other Clearances by Neothermia Corp.

    K Number Device Name
    K041347 MODIFICATION TO EN-BLOC BIOPSY SYSTEM
    K023413 MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM
    K022296 MODIFICATION TO EN-BLOC BIOPSY SYSTEM
    K021577 MODIFICATION TO EN-BLOC BIOPSY SYSTEM
    K020031 EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302
    K003190 EN BLOC BIOPSY SYSTEM