BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SURGICRAFT COPELAND DISPOSABLE

    K Number: K844608 · Decision May 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    155

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    Basic Information

    Device Name
    SURGICRAFT COPELAND DISPOSABLE
    K Number
    K844608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2675
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    A.W. Showell (Surgicraft) , Ltd.
    Date Received
    November 27, 1984
    Decision Date
    May 1, 1985
    Product Code
    HGP
    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
    HGP Electrode, Circular (Spiral), Scalp And Applicator

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    Other Clearances by A.W. Showell (Surgicraft) , Ltd.

    K Number Device Name
    K853033 HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM