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

    ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE

    K Number: K000612 · Decision Apr 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    11
    Review Days
    61

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    Basic Information

    Device Name
    ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
    K Number
    K000612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inrad
    Date Received
    February 23, 2000
    Decision Date
    April 24, 2000
    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 Inrad

    K Number Device Name
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    K093256 SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
    K090611 REVOLUTION FULL CORE BIOPSY
    K063238 ULTRACLIP II WING AND ULTRACLIP II COIL
    K042341 ULTRACLIP II US
    K041201 ULTRACLIP II MR
    K993785 ULTRACLIP TISSUE MARKER
    K981721 C0-AXIAL INTRODUCER NEEDLE
    K981166 ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214
    K980587 IV DECANTER-FLEXIBLE
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