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510(k) Data Aggregation

    K Number
    K243155
    Device Name
    Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
    Manufacturer
    Dongguan ZSR Biomedical technology Company Limited
    Date Cleared
    2025-02-11

    (134 days)

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

    Dongguan ZSR Biomedical technology Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single-Use Digital Flexible Ureteroscope (F-URS)(ZSR-URS-02, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) : This product is used in medical institutions, in conjunction with our electronic endoscope image processor. for imaging in examination, diagnosis or treatment of urinary system diseases. Endoscope Imaging Processor (ZSR-EOS10) : Applicable to medical institutions, which are connected with electronic endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors.
    Device Description
    Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Single-Use Digital Flexible Ureteroscope (F-URS) is used in medical institutions, in conjunction with our electronic endoscope image processor, for imaging in examination, diagnosis or treatment of urinary system diseases. This device uses ethylene oxide (EO) sterilization process. This product consists of two main parts: an operating handle with directional control and connecting wires, as well as a flexible insertion tube. Electronic Endoscope Imaging Processor (ZSR-EOS10) Applicable to medical institutions, which are connected with electronic endoscopes during endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors. The device is composed of aluminum alloy chassis and motherboard and power supply components. The Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) and Electronic Endoscope Imaging Processor make up the video ureteroscope system.
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    K Number
    K241181
    Device Name
    Disposable Ureteral Guide Sheath
    Manufacturer
    Dongguan ZSR Biomedical technology Company Limited
    Date Cleared
    2024-08-02

    (95 days)

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

    Dongguan ZSR Biomedical technology Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract
    Device Description
    The propose device, Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. This device is divided into 4 types: Straight type (ZSR-UA), Y type (ZSR-UAY), W type (ZSR-UAW), Cross type (ZSR-UAC). The device is composed of guide sheath and dilator.The guide sheath consists of guide sheath tube and connector (straight, Y-shaped, W-shaped and cross-shaped). The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
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