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510(k) Data Aggregation

    K Number
    K243321
    Device Name
    Endoscopic Video Image Processor (RP-IPD-V1000F)
    Manufacturer
    Guangzhou Red Pine Medical Instrument Co., Ltd.
    Date Cleared
    2025-02-07

    (107 days)

    Product Code
    FET, 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
    The Endoscopic Video Image Processor is used in conjunction with the Single-Use Video Flexible Cysto-Nephroscope (Models: RP-U-C01F, RP-U-C01FS) to process the images collected by the video endoscope and send them to the display, and provide power for the endoscope.
    Device Description
    The Endoscopic Video Image Processor is a video processing system intended for use during endoscopic procedures. It receives and processes image signals from a compatible video endoscope and produces live video images during endoscopic procedures. Apart from the image processing functions, it also provides the power supply for the endoscope. The Endoscopic Video Image Processor is a reusable device. It does not require sterilization before use, as there is no direct/indirect patient contact. The device needs to be cleaned and disinfected before use. and the cleaning and disinfection method is outlined in the Instructions for Use.
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    K Number
    K241987
    Device Name
    Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
    Manufacturer
    Guangzhou Red Pine Medical Instrument Co., Ltd.
    Date Cleared
    2024-08-02

    (25 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
    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 device is suitable for professional healthcare facility environments such as hospitals and clinics.
    Device Description
    The subject device, 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 device is suitable for professional healthcare facility environments such as hospitals and clinics. The subject device consists of an endoscope (a hysteroscope) which includes an insertion portion and handle, and the following accessories: 2 pieces of two-way valves and 1 piece of silicone cap.
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    K Number
    K241500
    Device Name
    Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
    Manufacturer
    Guangzhou Red Pine Medical Instrument Co., Ltd.
    Date Cleared
    2024-07-12

    (45 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
    Endoscopic Video Image Processor This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope. Single-Use Video Flexible Cysto-Nephroscope This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product shall not be used for other purposes.
    Device Description
    The proposed device, Cysto-Nephroscope System, which includes a Single-Use Video Flexible Cysto-Nephroscope and an Endoscopic Video Image Processor is intended for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney. The Single-Use Video Flexible Cysto-Nephroscope is available in two models with the different position of "U" and "D" mark on the handle and different deflection, RP-U-C01F, RP-U-C01F5. The Endoscopic Video Image Processor has only one model, RP-IPD-V2000EF. The Single-Use Video Flexible Cysto-Nephroscope is sterile and single-patient-use device. The Endoscopic Video Image Processor is nonsterile and multi-patient-use device, and it will be cleaned and disinfected before first use and after each use.
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    K Number
    K232043
    Device Name
    Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
    Manufacturer
    Guangzhou Red Pine Medical Instrument Co., Ltd.
    Date Cleared
    2024-02-16

    (221 days)

    Product Code
    FDF, FDS, FET
    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
    Endoscopic Video Image Processor: This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope. Single-Use Video Gastroscope: This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of upper digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults. Single-Use Video Colonoscope: This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of lower digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults.
    Device Description
    The proposed device, Digestive Endoscopy System, which includes a Single-Use Video Gastroscope and Single-Use Video Colonoscope, and Endoscopic Video Image Processor is intended for observation, diagnosis, photography and treatment of the upper and lower gastrointestinal tract. The Single-Use Video Gastroscope is available in two models with different length of image processor connection section, RP-Gl-G02A, RP-Gl-G02B. The Single-Use Video Colonoscope is available in two models with different length of image processor connection section and different diameters, RP-GI-C02B. The Endoscopic Video Image Processor is available in four models with disk space, RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D. The Single-Use Video Gastrocope and Single-Use Video Colonoscope are sterile and single-patient-use device. The Endoscopic Video lmage Processor is non-sterile and multi-patient-use device, and it will be cleaned and disinfected before first use.
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    K Number
    K221158
    Device Name
    Single-Use Video Flexible Ureterorenoscope System
    Manufacturer
    Guangzhou Red Pine Medical Instrument Co., Ltd.
    Date Cleared
    2023-03-06

    (319 days)

    Product Code
    FGB
    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
    The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.
    Device Description
    The Single-Use Video Flexible Ureterorenoscope System consists of a sterile Single-Use Video Flexible Ureterorenoscope (consists of handle and insertion portion) and an Endoscopic Video Image Processor (the video system, touch PC ) with its accessories power adapter, footswitch.The Ureterorenoscope is provided sterile (sterilized by EO) and intended to be single-use.The video system is powered by the main line. The handle includes a deflection lever, a lever lock, and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion portion contains one working channel and wiring to transmit the image signals to the Video Image Processor. The distal bending section of the insertion portion controlled by the user via the deflection lever on the handle. The distal end of the insertion portion contains a CMOS sensor for capturing image and transmitting it to the Video Image Processor, LEDs for illumination, and the distal opening of the working channel. The video cable connects the endoscope handle to the Video Image Processor, which provides power and processes video signals from the endoscope. Flexible Ureterorenoscope has the following physical and performance characteristics: - Flexible insertion portion - Camera and LED light source at the distal tip
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