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510(k) Data Aggregation

    K Number
    K221965
    Device Name
    FemDx FalloView
    Manufacturer
    FemDx Medsystems, Inc.
    Date Cleared
    2023-03-17

    (255 days)

    Product Code
    MKO, HIH
    Regulation Number
    884.1690
    Why did this record match?
    Product Code :

    MKO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemDx FalloView™ is intended for visualization of the cervical canal, uterine cavity, and proximal fallopian tube(s) during diagnostic gynecological procedures.
    Device Description
    The FemDx FalloView™ is a disposable, hand-held, battery-operated endoscope that contains a 4.7 mm hysteroscopic cannula, a 1.2 mm falloposcopic catheter, and a visualization system. The catheter is integrated inside the cannula center lumen and can be deployed, retracted, or rotated. The cannula includes a lumen and a proximal female luer lock port for saline irrigation. The visualization system includes a camera module positioned at the tip of the catheter, a controller board, an LCD display integrated into the device's handle, and LED/fiber optic illumination. The FemDx FalloView™ contains embedded software designed to display the real time image on the LCD display, control the illumination light level, and capture a screenshot. The captured image can be transmitted to a computer via Bluetooth and then accessed using the FalloView™ Image Viewer, a separate PC based software application.
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    K Number
    K974028
    Device Name
    STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
    Manufacturer
    CONCEPTUS, INC.
    Date Cleared
    1998-01-21

    (90 days)

    Product Code
    MKO
    Regulation Number
    884.1690
    Why did this record match?
    Product Code :

    MKO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STARRT System is indicated for use as a secondary diagnostic tool for the further evaluation of women previously diagnosed with proximal tubal occlusion by hysterosalpingography or selective salpingography.
    Device Description
    The Conceptus Stargate Catheter is a single lumen device with a graded shaft flexibility. The distal end has a diamond shaped wire tip designed to guide the catheter and to keep fallopian tube epithelium away from the falloposcope lens during imaging. The hub located at the proximal end of the Conceptus Stargate Catheter has two ports. The sideport is used for the attachment of the Trifurcated Irrigation Tubing set. The endport serves as a conduit for the introduction of the Conceptus Falloposcopy Guidewire and Falloposcope. The Conceptus Stargate Catheter and Falloposcopy Guidewire are transcervically delivered into the fallopian tube ostium through the lumen of the Coaxess™ Catheter which is delivered into the uterine cavity through the working channel of a rigid hysteroscope and positioned at the tubal ostium under hysteroscopic guidance. The Conceptus Stargate Catheter and Falloposcopy Guidewire are designed for use within the proximal portion of the fallopian tube (the first 2-3 cm of the tube).
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    K Number
    K962587
    Device Name
    CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
    Manufacturer
    CONCEPTUS, INC.
    Date Cleared
    1997-01-31

    (214 days)

    Product Code
    MKO
    Regulation Number
    884.1690
    Why did this record match?
    Product Code :

    MKO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conceptus FTCM System is intended for use in selective catheterization/cannulation of the fallopian tubes in order to evaluate proximal tubal occlusion or patency under direct visualization.
    Device Description
    The FTCM System combines well-established procedures of HSG, co-axial catheterization and microendoscopy. The FTCM System is composed of the following components: Soft Seal Cervical Catheter, Soft Torque Uterine Catheter and Accessory Valve, and/or Articulating Tip Hysteroscope, Variable Softness Catheter, guidewires: the Robust Guidewire, the Traveler Guidewire, the Supple Guidewire and the Pirouette Guidewire, and a Microendoscope with Eyepiece.
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    K Number
    K963580
    Device Name
    IMAGYN FALLOPOSCOPY SYSTEM
    Manufacturer
    IMAGYN MEDICAL, INC.
    Date Cleared
    1997-01-31

    (147 days)

    Product Code
    MKO
    Regulation Number
    884.1690
    Why did this record match?
    Product Code :

    MKO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imagyn Falloposcopy System is indicated for intratubal catheterization for evaluation of occlusions in the fallopian tube.
    Device Description
    The Imagyn Falloposcopy System consists of the following components: Linear Everting (LE) Fallopian Tube Access Catheter Falloposcope
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