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510(k) Data Aggregation

    K Number
    K190797
    Device Name
    Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
    Date Cleared
    2019-11-18

    (235 days)

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

    Reed Medical (Zhejiang) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reedgyn disposable hysteroscope RH-2D-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures in an outpatient or office setting. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain. The Reedgyn disposable hysteroscope RH-2S-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recogmized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.
    Device Description
    The Reedgyn disposable hysteroscopes, which include models RH-2S-01 and RH-2D-01, are used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures (both RH-2S-01 and RH-2D-01) and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting (RH-2S-01 only). RH-2S-01 and RH-2D-01 are similar in design. The only difference between RH-2S-01 and RH-2D-01 is: RH-2S-01 is intended for performing diagnostic procedures and obtaining an endometrial tissue sample (biopsy), while the RH-2D-01 is intended for performing diagnostic procedures only. The Reedgyn disposable hysteroscopes consist of a lightweight handle, a cannula integrated with a camera and a light source at the distal end to illuminate the area for visualizing images. The distal end of the cannula is equipped with a camera module including a camera and LED lightling. LED irradiates the surface of the object, and the reflected light enters the image processor through a lens and converts it into electrical signals, and then converted into a digital image signal , which is transmitted to the digital signal processing chip. After chip processing, the signal is transmitted to PC through USB interface. The Reedgyn disposable hysteroscopes should be operated together with Reedgyn hysteroscope imaging software which was installed to a Microsoft Windows PC station. (Note: the Windows PC station is not included in the product configuration.)
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