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

    I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE

    K Number: K120002 · Decision Jun 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    31
    Review Days
    175

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    Basic Information

    Device Name
    I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
    K Number
    K120002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Busse Hospital Disposables, Inc.
    Date Received
    January 3, 2012
    Decision Date
    June 26, 2012
    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 Busse Hospital Disposables, Inc.

    K Number Device Name
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    K073222 MODIFICATION TO:SPECIALTY NEEDLES
    K070465 BUSSE EPIDURAL CATHETER
    K063018 GLASS LOSS OF RESISTANCE SYRINGE
    K061394 SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
    K061570 I-STYLE BONE MARROW ASPIRATION NEEDLE
    K052843 BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
    K032432 BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
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