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510(k) Data Aggregation

    K Number
    K240663
    Device Name
    Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
    Manufacturer
    Guangzhou Red Pine Medical Instrument Co.,Ltd.
    Date Cleared
    2024-06-21

    (105 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Red Pine Medical Instrument Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K232003
    Device Name
    Endoscopic Video Image Processor, Single-Use Video Hysteroscope
    Manufacturer
    Guangzhou Red Pine Medical Instrument Co.,Ltd.
    Date Cleared
    2024-02-12

    (221 days)

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

    Guangzhou Red Pine Medical Instrument Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. The devices is suitable for professional healthcare facility environments such as hospitals and clinics.
    Device Description
    The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity and it is provided sterile (sterilized by EO) and intended for single use only. The Single-Use Video Hysteroscope is composed of a handle part, including the video cable interface, working channel port and instrument channel port, and an insertion portion, of which a camera module and LED light source are integrated inside the distal tip. There are two models of The Single-Use Video Hysteroscope, RP-G-C24 and RP-G-C0101. The model RP-G-C24 is identical to RP-G-C0101 except for the direction of view, width size of insertion port and width size of instrument channel. The principle of optical imaging: the light source illuminates the inspected site of the patient, which is imaged by the photosensitive surface of CMOS camera module. The optical signal received by the CMOS sensor is converted into electrical signal after processing. The electrical signal is then transmitted by the cable to the signal processing chip embedded on the Endoscopic Video Image Processor where it is restored after processing and finally displayed on the screen of Endoscopic Video Image Processor.
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