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

    UROTEK RE-USABLE FIBEROPTIC CABLE

    K Number: K951933 · Decision May 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    5
    Review Days
    31

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    Basic Information

    Device Name
    UROTEK RE-USABLE FIBEROPTIC CABLE
    K Number
    K951933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Energy Life Systems Corp.
    Date Received
    April 25, 1995
    Decision Date
    May 26, 1995
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Energy Life Systems Corp.

    K Number Device Name
    K945560 UROTEK LASER CATHETER
    K945563 CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))
    K943409 SIDE-FIRING UROLOGIC REFRACTIVE FIBER
    K934389 UROTEK LASER CATHETER