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

    HOLGRATH METAL-HUB, EPIDURAL NEEDLE

    K Number: K946047 · Decision Jul 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    151
    Applicant Total
    6
    Review Days
    225

    Basic Information

    Device Name
    HOLGRATH METAL-HUB, EPIDURAL NEEDLE
    K Number
    K946047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    HOLGRATH MEDICAL TECHNOLOGIES, INC.
    Date Received
    December 12, 1994
    Decision Date
    July 25, 1995
    Product Code
    BSP
    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
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

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    Other Clearances by HOLGRATH MEDICAL TECHNOLOGIES, INC.

    K Number Device Name
    K954835 HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET
    K944906 HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE
    K944907 HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE
    K944905 HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE
    K944908 HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE