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510(k) Data Aggregation

    K Number
    K972426
    Device Name
    MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH
    Manufacturer
    IMAGYN MEDICAL, INC.
    Date Cleared
    1997-09-23

    (88 days)

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

    IMAGYN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The MicroSpan Hysteroscope Sheath is used to provide access to the uterine cavity for the MicroSpan Gold Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.
    Device Description
    The MicroSpan-Gold Hysteroscope is a small diameter, rigid, fiberoptic hysteroscope without through lumens. The device consists of an outer stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At one end of the imaging bundle is the distal lens and at the other is the rotatable eyepiece. An endoscopic light source is connected to the light post of the hysteroscope through compatible light cables. If desired, the eyepiece can be connected through a focusing optical coupler to a camera head which carries the image by cable to the camera. The MicroSpan Hysteroscope Sheath is offered with irrigation/insufflation and aspiration ports and an instrument channel. The device is provided sterile for single use, and is made from both metal and plastic components.
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    K Number
    K970750
    Device Name
    MICROSPAN INSEMINATION SYSTEM
    Manufacturer
    IMAGYN MEDICAL, INC.
    Date Cleared
    1997-05-05

    (63 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMAGYN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for intrauterine insemination. The MicroSpan Delivery Catheter is designed to fit through the larger diameter MicroSpan Access Catheter for delivery of washed spermatozoa to the uterine cavity or for laparoscopic instillation and/or aspiration of media. Laparoscopically, the device is specifically intended for use to aspirate ascitic fluids, aspirate fluid from the cul-de-sac for cytologic screening and bacteriologic cultures, irrigation and aspiration of larger volumes of fluid from ovarian tumors, irrigation and rinsing of the operative field, aspiration of bloody fluid resulting from a tubal pregnancy or post operative bleeding, and instillation of sterile saline or Ringer's solution.
    Device Description
    The MicroSpan Insemination System is a sterile device consisting of two components: the MicroSpan Access Catheter (introducer) and the MicroSpan Delivery Catheter. The MicroSpan Insemination System is designed to be introduced through the MicroSpan Hysteroscope Sheath for intrauterine insemination procedures or introduced through the operative channel of a laparoscope for laparoscopic instillation and/or aspiration of media.
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    K Number
    K971255
    Device Name
    IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
    Manufacturer
    IMAGYN MEDICAL, INC.
    Date Cleared
    1997-04-21

    (17 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMAGYN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imagyn Expandable Laparoscopic Introducer is indicated for use in providing access to the peritoneal cavity for diagnostic and operative instruments during laparoscopic procedures.
    Device Description
    The Imagyn Expandable Laparoscopic Introducer is a single use, sterile device made from both metal and plastic components. For second-site use during laparoscopic procedures, the device incorporates a valve system that maintains adequate insufflation pressures while diagnostic or operative instruments are in use.
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    K Number
    K965055
    Device Name
    IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
    Manufacturer
    IMAGYN MEDICAL, INC.
    Date Cleared
    1997-03-06

    (78 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMAGYN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroLap ™ and MicroLap Gold Laparoscopes are used to permit viewing of the abdominal cavity for the purpose of performing diagnostic and surgical procedures.
    Device Description
    The MicroLap ™ and MicroLap Gold Laparoscopes are small diameter, rigid, fiberoptic laparoscopes without through lumens. The devices consist of an outer stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At one end of the imaging bundle is the distal lens and at the other is the rotatable eyepiece. An endoscopic light source is connected to the light post of the laparoscopes through compatible light cables. If desired, the eyepiece can be connected through a focusing optical coupler to a camera head which carries the image by cable to the camera.
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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?
    Applicant Name (Manufacturer) :

    IMAGYN MEDICAL, INC.

    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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    K Number
    K961688
    Device Name
    MICROSPAN HYSTEROSCOPE
    Manufacturer
    IMAGYN MEDICAL, INC.
    Date Cleared
    1996-10-15

    (167 days)

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

    IMAGYN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroSpan Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
    Device Description
    The MicroSpan Hysteroscope is a small diameter, rigid, fiberoptic hysteroscope without through lumens. The device consists of an outer stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At one end of the imaging bundle is the distal lens and at the other is the rotatable eyepiece. An endoscopic light source is connected to the light post of the hysteroscope through compatible light cables. If desired, the eyepiece can be connected through a focusing optical coupler to a camera head which carries the image by cable to the camera.
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    K Number
    K961506
    Device Name
    MICROSPAN HYSTEROSCOPE SHEATH
    Manufacturer
    IMAGYN MEDICAL, INC.
    Date Cleared
    1996-07-03

    (75 days)

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

    IMAGYN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroSpan Hysteroscope Sheath is indicated for use in providing access to the uterine cavity for the Imagyn Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.
    Device Description
    The MicroSpan Hysteroscope Sheath is offered with irrigation/insufflation and aspiration ports and an instrument channel. The device is provided sterile, for single-use, and is made from both metal and plastic components.
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