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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    CONCEPTUS, INC.

    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
    K972210
    Device Name
    RESECTOSCOPE SAFETY SHEATH
    Manufacturer
    CONCEPTUS, INC.
    Date Cleared
    1997-09-05

    (86 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONCEPTUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ERA Sheath is indicated for use during the resection and/or ablation of unwanted or diseased uterine tissue.
    Device Description
    The ERA Sheath is a tubular sheath device incorporating an electrosurgical return electrode. The Sheath is designed to fit over the shaft of a standard gynecological resectoscope to act as an electrical return, thereby, obviating the need for an electrosurgical dispersive pad. The design of the Sheath enables a uterine tissue resection or ablation procedure to be performed in isotonic solution instead of hypotonic solutions which are currently used in these procedures, thereby eliminating the risk of hyponatremia. The ERA Sheath is composed of four structural elements: 1) a non-conductive sheath material which is placed over a standard continuous flow resectoscope, 2) a return electrode located on the distal end of the sheath with a conductor that runs along the sheath's surface to the proximal end of the sheath, 3) a standard wire connector lead which is used to attach the sheath to the return/patient outlet on the electrosurgical generator, and 4) an insulating outer jacket which is configured to expose the distal electrodes.
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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?
    Applicant Name (Manufacturer) :

    CONCEPTUS, INC.

    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
    K954164
    Device Name
    HYSTEROSCOPE
    Manufacturer
    CONCEPTUS, INC.
    Date Cleared
    1996-03-12

    (189 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONCEPTUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conceptus hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix for both diagnostic and operative procedures.
    Device Description
    The Conceptus hysteroscope has a rigid shaft with a flexible articulating tip. The device is equipped with a separate eyepiece plug and light guide plug. The optical system conveys an image to the user's eye or to a video camera.
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