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510(k) Data Aggregation

    K Number
    K062222
    Device Name
    UNITIP HIGH RESOLUTION CATHETER
    Manufacturer
    UNISENSOR AG
    Date Cleared
    2007-03-15

    (225 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNISENSOR AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The catheter probe is used to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data. The device is manufactured in the basic model variations listed below: 1. High Resolution Gastrointestinal Catheter with up to 40 pressure sensors: This model variation is intended for simple direct esophageal pressure, either at, above, or below the specific site of interest. Pressure information is provided at multiple sensor sites. Pressures may be measured continuously, at rest, or dynamically. 2. Gastrointestinal catheter, with pH sensors: This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except that this model variation includes up to 7 pH sensors. PH probes are added to allow measurements of pH in the stomach and/or esophagus. 3. Gastrointestinal catheter, with sleeve: This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except one or more of the pressure sensor sites will include a sleeve. The sleeve is added to broaden the pressure sensitive one for the sensor site, and reduce positioning sensitivity. 4. Gastrointestinal catheter, with impedance rings: This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes up to 14 conductive rings for impedance studies. 5. Gastrointestinal catheter, with lumen This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes a lumen.
    Device Description
    The Unisensor UniTip Gastrointestinal Pressure Sensor Catheter product line consists of multiple ultra-miniature solid-state pressure sensors, located at the distal end of a gastrointestinal catheter. pH sensors, silicon rubber sleeves, lumen, and conductive impedance rings, may also be included. There are scanning electronics for multiplexing the sensor signals, and an electrical connection located at the proximal end to carry the sensor element signals to an external gastrointestinal motility recording equipment. The UniTip GI catheters are produced in various lengths and catheter sizes. This modification consists of increasing the maximum number of pressure sensor elements to 40. The closer proximity of the pressure sensor elements to each other allows for high-resolution mapping of pressures within the organs of the human gastrointestinal tract. This modification also increases the maximum number of pH sensors to 7, and the maximum number of impedence rings to 14.
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    K Number
    K003580
    Device Name
    UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
    Manufacturer
    UNISENSOR AG
    Date Cleared
    2001-07-31

    (253 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNISENSOR AG

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