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

    GIBBONS STERILE TROCAR KITS

    K Number: K012198 · Decision Aug 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    GIBBONS STERILE TROCAR KITS
    K Number
    K012198
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gibbons Surgical Corp.
    Date Received
    July 13, 2001
    Decision Date
    August 9, 2001
    Product Code
    FBQ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FBQ Trocar, Gastro-Urology

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    Other Clearances by Gibbons Surgical Corp.

    K Number Device Name
    K010779 MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT