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

    GYNEX EXTENDED REACH NEEDLE

    K Number: K980238 · Decision Aug 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    210

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    Basic Information

    Device Name
    GYNEX EXTENDED REACH NEEDLE
    K Number
    K980238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gynex Corp.
    Date Received
    January 23, 1998
    Decision Date
    August 21, 1998
    Product Code
    HEE
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HEE Set, Anesthesia, Paracervical

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    Other Clearances by Gynex Corp.

    K Number Device Name
    K061306 CO-1000 COLPOSCOPE, MULTIPLE
    K982739 GYNEX ELECTRODES
    K980237 GYNEX ENDOSPECULUM
    K980247 GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM