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510(k) Data Aggregation

    K Number
    K193250
    Device Name
    Irrigation Tubing with CO2 or Air
    Manufacturer
    KeyMed (Medical and Industrial Equipment) Ltd.
    Date Cleared
    2020-04-06

    (133 days)

    Product Code
    OCX
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    **KeyMed (Medical **and Industrial Equipment) Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or ar insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.
    Device Description
    The proposed device consists of four separate labelled tube set devices in total, two tube sets (MAJ-2207 & MAJ-2208) designed to be used with CO2 with differing bottle cap thread variants: and two tube sets (MAJ-2209 & MAJ-2210) designed to be used with Air with differing bottle cap thread variants to fit a variety of on the market branded disposable sterile bottles.
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    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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    K Number
    K100899
    Device Name
    OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Date Cleared
    2010-09-13

    (166 days)

    Product Code
    FEQ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    **KEYMED (MEDICAL **& INDUSTRIAL EQUIPMENT), LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OLYMPUS FLUSHING PUMP (OFP-2) and its accessories are intended for use during endoscopic procedures to wash blood, feces and other organic matter from the gastric and colonic mucosa site being visualized, diagnosed and to aid in the filling areas of the gastrointestinal tract with water in order to aid in examinations preformed with trans-endoscopic ultrasound probes.
    Device Description
    The Olympus Endoscopic Flushing Pump (OFP-2) is a motorised pump designed to transfer water from a bottle, via a tube, to an endoscope. The OFP-2 uses a peristalic pump head to move the water through the tube. The speed of rotation of the pump head is adjustable by the user, over nine steps, using flow control buttons on the front of the pump. The flow control buttons are connected to a digital controller that governs speed of rotation of the pump head. Nine LEDs on the front of the pump indicate the speed setting that has been selected. The pump is operated by a footswitch or a button on the endoscope. It has an on/off button and a standby button. The OFP includes a water container supplied non-sterile to be processed before use. Two water tubes of different lengths and an instrument channel adapter are supplied sterile. The Instrument Channel Adapter (MAJ-1606) and Instrument Channel Water Tube (MAJ-1607) are supplied sterile for single use only. to pump water through the instrument channel of the endoscope. The Auxilliary Channel Water Tube (MAJ-1608) is supplied sterile for single day only use.
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    K Number
    K011725
    Device Name
    OLYMPUS SUCTION PUMP, MODEL KV-5
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Date Cleared
    2001-08-31

    (88 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    **KEYMED (MEDICAL **& INDUSTRIAL EQUIPMENT), LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not intended for thoracic, domiciliary, field or transport use.
    Device Description
    Not Found
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    K Number
    K000948
    Device Name
    OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Date Cleared
    2000-05-12

    (50 days)

    Product Code
    FEQ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    **KEYMED (MEDICAL **& INDUSTRIAL EQUIPMENT), LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962528
    Device Name
    OLYMPUS MOBILE CHAIR/COUCH
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Date Cleared
    1996-12-12

    (168 days)

    Product Code
    FZK
    Regulation Number
    878.4950
    Why did this record match?
    Applicant Name (Manufacturer) :

    **KEYMED (MEDICAL **& INDUSTRIAL EQUIPMENT), LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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