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

    LABORIE FIBREOPTIC LIGHT CABLE

    K Number: K840605 · Decision Apr 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    25
    Applicant Total
    7
    Review Days
    63

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    Basic Information

    Device Name
    LABORIE FIBREOPTIC LIGHT CABLE
    K Number
    K840605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Tridak Division of Indicon, Inc.
    Date Received
    February 10, 1984
    Decision Date
    April 13, 1984
    Product Code
    FFS
    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
    FFS Image, Illumination, Fiberoptic, For Endoscope

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    Other Clearances by Tridak Division of Indicon, Inc.

    K Number Device Name
    K891007 NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
    K860744 OPTHALMIC SURGICAL INSTRUMENTS
    K853059 LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE
    K852856 LABORIE URODYNAMICS PROCESSOR
    K851934 CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA
    K842609 R.L. MEDICAL TWIN LIGHT SOURCE