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

    REGANES SPINAL NEEDLE (VARIOUS)

    K Number: K971645 · Decision Aug 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    9
    Applicant Total
    9
    Review Days
    88

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    Basic Information

    Device Name
    REGANES SPINAL NEEDLE (VARIOUS)
    K Number
    K971645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avid N.I.T., Inc.
    Date Received
    May 5, 1997
    Decision Date
    August 1, 1997
    Product Code
    MIA
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MIA Needle, Spinal, Short Term

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    Other Clearances by Avid N.I.T., Inc.

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    K973638 N.I.T., INC. NEEDLE GUIDING TEMPLATE
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