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

    VACUUM ASSISTED CORE BIOPSY DEVICE

    K Number: K042290 · Decision Oct 6, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    3
    Review Days
    43

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    Basic Information

    Device Name
    VACUUM ASSISTED CORE BIOPSY DEVICE
    K Number
    K042290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Suros Surgical Systems, Inc.
    Date Received
    August 24, 2004
    Decision Date
    October 6, 2004
    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 Suros Surgical Systems, Inc.

    K Number Device Name
    K062528 TISSUE SITE MARKING SYSTEM
    K034021 VACUUM ASSISTED CORE BIOPSY DEVICE