BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    GENERAL IVT NEEDLE GUIDE KIT, STERILE

    K Number: K892070 · Decision Sep 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    35
    Applicant Total
    10
    Review Days
    158

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    Basic Information

    Device Name
    GENERAL IVT NEEDLE GUIDE KIT, STERILE
    K Number
    K892070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2960
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Amedic USA
    Date Received
    March 31, 1989
    Decision Date
    September 5, 1989
    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

    K Number Device Name
    K897120 EQUIP COVERS, STERILE
    K892071 GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE
    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
    K864219 TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE