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510(k) Data Aggregation

    K Number
    K122818
    Device Name
    OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE
    Manufacturer
    OLYMPUS KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LT
    Date Cleared
    2013-01-04

    (112 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    **OLYMPUS KEYMED (MEDICAL **& INDUSTRIAL EQUIPMENT) LT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus MAJ-172 Instrument Tray for LTF Videoscope is intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam or ethylene oxide sterilization of the enclosed medical device. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a purpose designed transport and sterilization case indicated for use in medical facilities to accommodate an endoscope from the Olympus LTF range of videoscopes, plus certain identified accessories, for reprocessing by autoclaving (steam) or ETO sterilization (depending on the model). LTF Type 160 and VH videoscopes are compatible with Steam and ETO sterilization cycles. LTF Type V3 and VP are compatible only with ETO sterilization cycles. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is designed to secure and store a single videoscope and its accessories for sterilization at a healthcare facility. Refer to the instrument tray instructions for use for the proper orientation of the videoscope and accessories within the instrument tray. The recommended sterilization cycles for the LTF videoscopes are as follows: ETO Sterilization .. . .. 100% ETO concentration: 735 mg/L Temp: 57 °C -------------Relative Humidity: 70% Processing (Hold) Time: 1 hour Aeration Time: 12 hours Steam Sterilization: Vacuum: 0.016 MPa minimum Pressure: 0.101 MPa minimum Temp: 135 °C Exposure Time: 3 minutes Drving Time: 20 minutes
    Device Description
    The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a polymer tray with a perforated lid intended to secure an endoscope and accessories during exposure to gaseous sterilization methods.
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