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510(k) Data Aggregation

    K Number
    K130304
    Device Name
    LMA FAMILY OF AIRWAYS
    Manufacturer
    THE LARYNGEAL MASK CO.,LTD.
    Date Cleared
    2014-05-30

    (477 days)

    Product Code
    CAE, BTR
    Regulation Number
    868.5110
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE LARYNGEAL MASK CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LMA Unique™, LMA Classic™, LMA Classic Excel™, LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™ are devices inserted into a patient's pharynx through the mouth to provide a patent airway. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field. The LMA Fastrach™ ETT (reusable) and LMA Fastrach™ ETT Single Use are indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
    Device Description
    The LMA™ family of airways includes 2 types of airways: Generically referred to as supraglottic airways and Tracheal Tubes specific for use with the LMA Fastrach™ device. The supraglottic airways are airways that incorporate a large cuff that sits above the glottic opening and the opposite end has a standard 15 mm OD connector that connector to a gas source. The LMA Flexible™ is the same as the Classic™ except that the shaft is wire reinforced allowing for great flexibility. The LMA ProSeal™ which has a second lumen for drainage. The LMA Fastrach™ single use which has a rigid handle to assist with insertion. The LMA Fastrach™ ETT and LMA Fastrach™ ETT Single Use is straight, cuffed, wire reinforced tracheal tube that is designed to be used with the LMA Fastrach™ supraglottic airway.
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    K Number
    K062475
    Device Name
    LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
    Manufacturer
    THE LARYNGEAL MASK CO.,LTD.
    Date Cleared
    2007-05-09

    (258 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE LARYNGEAL MASK CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LMA StoneBreaker™ is indicated for use via a rigid or semi-rigid endoscope with a straight working channel, for the fragmentation of urinary tract (i.e. kidney, ureter and bladder) stones.
    Device Description
    The LMA StoneBreaker™ is a portable, non-electrical, pneumatic contact intracorporeal lithotripter, intended for use to fragment stones in the urinary tract (i.e. kidney, ureter and bladder). Its weight of approximately 500g with a probe, and with no extraneous electrical or pneumatic connections, makes this device highly portable. It is recommended for use with endoscopes equipped with a straight working channel. The device is powered by a detachable cartridge of high pressure carbon dioxide gas, with a maximum pre-adjusted operating pressure of 31 bars. The mechanical shock generated by the device is transferred through the length of the probe to the tip, which is in direct contact with the stone to be fragmented, providing high speed fragmentation of the calculus in situ. Three sizes of probe (1.0mm, 1.6mm and 2.0mm) are available for use with the LMA StoneBreaker™ A LMA StoneBreaker™ Carbon Dioxide (CO2) gas cartridge provides the necessary energy for one surgical procedure. Once the cartridge is perforated by the built-in screw system, the compressed gas passes through a pre-adjusted pressure regulator in the device and a mechanical shockwave required for fragmentation of urinary stone is generated when the trigger is depressed. Expended gas will leave the device through a specially designed exhaust port and the attached exhaust line The trigger snaps back to its starting position when the gas is expended through the exhaust port, and the device is now ready for further use. The LMA StoneBreaker™, Probes, Exhaust Line and accessories are delivered non-sterile and it must be cleaned, disinfected and sterilized before initial use and before each subsequent use.
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    K Number
    K051993
    Device Name
    LMA FASTRACH ETT SINGLE USE
    Manufacturer
    THE LARYNGEAL MASK CO.,LTD.
    Date Cleared
    2005-12-13

    (141 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE LARYNGEAL MASK CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LMA Fastrach™ ETT SU is intended to be inserted through the patient's mouth into the trachea to maintain an open airway and is attached to the anesthesia machine after insertion into the patient. It is intended that the user will be able to inflate the device cuff and ventilate the patient. The LMA Fastrach™ ETT SU is indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking of the tube when movement of the head or neck is required following intubation.
    Device Description
    The LMA Fastrach™ ETT SU is a straight, cuffed, wire-reinforced, single use tracheal tube with a Murphy Eye. The metal wire spiral reinforcement is to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery. The plastic material and the spring allow the tube to be easily bent in all direction. The plastic material and the spring prevent kinking or occlusion of the tube. The cuff is intended to provide a seal against the trachea, ensuring that Inspiratory and expiratory gasses are directed through the tube and not allowed to escape to the patients "upper" airway, thus preventing loss of ventilation and aspirated stomach contents from entering the lungs. This reinforced tracheal tube is available in size 6, 6.5, 7.0, 7.5 and 8.0 mm only, and it is designed to be compatible with the LMA Fastrach™, LMA Fastrach™ SU and LMA CTrach Airways.
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    K Number
    K991580
    Device Name
    ILM ENDOTRACHEAL TUBE
    Manufacturer
    THE LARYNGEAL MASK CO.,LTD.
    Date Cleared
    2000-02-04

    (273 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE LARYNGEAL MASK CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ILM Endotracheal Tube is indicated for airway management by oral intubation of the trachea.
    Device Description
    The ILM ETT is a straight, cuffed, wire-reinforced tracheal tube, with a Murphy Eye. It is available in a three sizes with internal diameters of 7.0mm, 7.5mm and 8.0mm. The airway tube is made from silicone and features a stainless steel reinforcing wire to prevent kinking or occlusion of the tube. The tip of the tube is molded from a softer grade of silicone for passage through the vocal cords. The airway tube features an inflatable silicone cuff for sealing the tube in the trachea. The tip of the ILM ETT is beveled in two directions to aid passage of the tube through the trachea. Depth markings are printed on the airway tube (in centimeters). These indicate the distance to the distal tip of the tube. The tube also has a printed black line to indicate its caudal surface. The ILM ETT features a small diameter silicone tube connected to a pilot balloon with a luer check valve for inflation of the cuff. The ILM ETT can be connected to the anesthesia circuit by a removable 15mm standard male connector which conforms to ISO5356-1 (1987). A connector is supplied with each ILM ETT. The ILM ETT is designed to be compatible with the LMA-Fastrach (an oropharyngeal airway). To ensure compatibility, a marker line indicates when the tube passes through the LMA-Fastrach. In addition, the inflation line is mounted close to the rear of the ILM ETT to ensure unobstructed passage of the tube through the LMA-Fastrach.
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