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

    ENDOPLUS hand-held laparoscopic instruments

    K Number: K151567 · Decision Dec 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    196

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    Basic Information

    Device Name
    ENDOPLUS hand-held laparoscopic instruments
    K Number
    K151567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endoplus
    Date Received
    June 10, 2015
    Decision Date
    December 23, 2015
    Product Code
    HFI
    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
    HFI Coagulator, Culdoscopic (And Accessories)

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