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

    TROCAR/CANNULA

    K Number: K945979 · Decision Dec 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    8
    Review Days
    13

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    Basic Information

    Device Name
    TROCAR/CANNULA
    K Number
    K945979
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Endoscopic Technologies, Inc.
    Date Received
    December 8, 1994
    Decision Date
    December 21, 1994
    Product Code
    GCJ
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Endoscopic Technologies, Inc.

    K Number Device Name
    K060101 ESTECH AORTIC EASY FLOW CANNULA
    K053326 ESTECH COBRA ELECTROSURGICAL UNIT & CABLE
    K053100 ESTECH COBRA BIPOLAR SYSTEM
    K946105 ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
    K945978 TUBING, NONINVASIVE
    K924057 DISPOSIBLE ELECTRO COAGULATION PROBE
    K922685 TROCARS