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

    TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE

    K Number: K864219 · Decision Mar 27, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    35
    Applicant Total
    10
    Review Days
    150

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    Basic Information

    Device Name
    TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
    K Number
    K864219
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2960
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Amedic USA
    Date Received
    October 28, 1986
    Decision Date
    March 27, 1987
    Product Code
    HGL
    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
    HGL Transducer, Ultrasonic, Obstetric

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    Other Clearances by Amedic USA

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    K892069 EXTENDED COVERS, STERILE
    K892068 TRT (ACUSON) NEEDLE GUIDE KIT, STERILE
    K871467 BIOPSY NEEDLE GUIDE KIT, STERILE
    K871565 ULTRASOUND TRANSDUCER GEL, STERILE
    K871609 ULTRASOUND TRANSDUCER SHEATHS, STERILE
    K871503 BIOPSY NEEDLE GUIDE KIT, STERILE