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

    PKS BILL

    K Number: K122605 · Decision Dec 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    15
    Applicant Total
    42
    Review Days
    100

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    Basic Information

    Device Name
    PKS BILL
    K Number
    K122605
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.4150
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gyrus Acmi, Inc.
    Date Received
    August 27, 2012
    Decision Date
    December 5, 2012
    Product Code
    HIN
    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
    HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)

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