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510(k) Data Aggregation

    K Number
    K241639
    Device Name
    Single-use Video Ureterorenoscope (SVU-220US)
    Manufacturer
    HUGER Medical Instrument Co., Ltd.
    Date Cleared
    2024-07-01

    (24 days)

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

    HUGER Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.
    Device Description
    The Single-use Video Ureterorenoscope (SVU-220US) is intended to be used with the HUGER'S Medical Video Processor (cleared in K230475). The Single-use Video Ureterorenoscope is a single use device. The Single-use Video Ureterorenoscope is consist of distal end, bending section, insertion portion, operational portion and connection portion. The Single-use Video Ureterorenoscope is a single-channel endoscope. Only one instrument channel is in the distal end of the endoscope.
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    K Number
    K230475
    Device Name
    Medical Video Endoscope System
    Manufacturer
    HUGER Medical Instrument Co., Ltd.
    Date Cleared
    2023-11-03

    (254 days)

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

    HUGER Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medical Video Endoscope System has been designed to be used with endo-therapy accessories such as a biopsy forcens and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney. Medical Video Processor is intended to be used in conjunction with the endoscopes to enhance and display the image of the field of view of the endoscope on the monitor, and also provides functional supply for the endoscope. Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.
    Device Description
    Medical Video Endoscope System is consist of a Single-use Video Ureterorenoscope and a Medical Video Processor. The proposed device has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. The Single-use Video Ureterorenoscope is a single use device. The Single-use Video Ureterorenoscope is consist of distal end, bending section, insertion portion, operational portion and connection portion. The Single-use Video Ureterorenoscope is a single-channel endoscope. Only one instrument channel is in the distal end of the endoscope. The Medical Video Processor is a reusable device. The Medical Video Processor is composed of a power circuit, an image processing circuit and software.
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