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

    MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT

    K Number: K010779 · Decision Apr 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    26

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    Basic Information

    Device Name
    MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
    K Number
    K010779
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gibbons Surgical Corp.
    Date Received
    March 15, 2001
    Decision Date
    April 10, 2001
    Product Code
    FHO
    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
    FHO Pneumoperitoneum Needle

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    Other Clearances by Gibbons Surgical Corp.

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