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

    AUTO SUTURE DISPOSABLE LIGHT CABLE

    K Number: K934531 · Decision May 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    30
    Applicant Total
    218
    Review Days
    240

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    Basic Information

    Device Name
    AUTO SUTURE DISPOSABLE LIGHT CABLE
    K Number
    K934531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    September 20, 1993
    Decision Date
    May 18, 1994
    Product Code
    FCW
    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
    FCW Light Source, Fiberoptic, Routine

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