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

    MONOPOLAR ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS

    K Number: K943958 · Decision Sep 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    23

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    Basic Information

    Device Name
    MONOPOLAR ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS
    K Number
    K943958
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tnco, Inc.
    Date Received
    August 15, 1994
    Decision Date
    September 7, 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 Tnco, Inc.

    K Number Device Name
    K940554 TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS
    K940552 MONOPOLAR SURGICAL INSTRUMENTS
    K940551 ENDOSCOPIC SURGICAL INSTRUMENTS