BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇸🇪 Sweden

    EXTENDED COVERS, STERILE

    K Number: K892069 · Decision Aug 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    0
    Applicant Total
    10
    Review Days
    130

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    Basic Information

    Device Name
    EXTENDED COVERS, STERILE
    K Number
    K892069
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Amedic USA
    Date Received
    March 31, 1989
    Decision Date
    August 8, 1989
    Product Code
    FFF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FFF Cover, Biopsy Forceps

    Other Clearances by Amedic USA

    K Number Device Name
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    K892070 GENERAL IVT NEEDLE GUIDE KIT, STERILE
    K892071 GENERAL (BIOPSY) NEEDLE GUIDE KIT, 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