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510(k) Data Aggregation

    K Number
    K061690
    Device Name
    SURGICAL HEADLIGHT
    Manufacturer
    GULF MEDICAL FIBEROPTICS
    Date Cleared
    2006-09-15

    (92 days)

    Product Code
    FST
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    GULF MEDICAL FIBEROPTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use for this particular device is to be worn on the surgeons head and to illuminate the body cavity during examinations or surgical procedures. This product is shipped to the end user non-sterile.
    Device Description
    Surgical Headlight
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    K Number
    K021931
    Device Name
    ENDOSCOPIC FIBEROPTIC CABLE
    Manufacturer
    GULF MEDICAL FIBEROPTICS
    Date Cleared
    2002-09-06

    (86 days)

    Product Code
    HBI, FFS
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    GULF MEDICAL FIBEROPTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Fiberoptic Cable is used to conduct visible light from a light source to an endoscope during a surgical procedure.
    Device Description
    Endoscopic Fiberoptic Cable
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