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510(k) Data Aggregation

    K Number
    K250785
    Device Name
    Single-use Flexible Ureteroscope
    Manufacturer
    Hunan Vathin Medical Instrument Co.Ltd
    Date Cleared
    2025-05-06

    (53 days)

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

    Hunan Vathin Medical Instrument Co.Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.
    Device Description
    The Single-use Flexible Ureteroscope is intended to be used with Vathin Digital Video Monitor. During diagnosis and treatment, the Single-use Flexible Ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible Ureteroscope converts the received mucosal reflected light signals into electrical signals, transmitted to the Digital Video Monitor through the cable, the Digital Video Monitor receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display. The Single-use Flexible Ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. It is for use in professional Healthcare Facility Environment.
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    K Number
    K242416
    Device Name
    Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL
    Manufacturer
    Hunan Vathin Medical Instrument Co.Ltd
    Date Cleared
    2025-01-16

    (154 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hunan Vathin Medical Instrument Co.Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single-use Flexible Bronchoscope has been designed to be used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. Single-use Sampler is designed as an add-on for use during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedures which enable aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung. The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation. The Video Bronchoscope System is for use in professional Healthcare Facility Environment.
    Device Description
    The Video Bronchoscope System consists of Single-use Flexible Bronchoscope, Single-use sampler and digital video monitor. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The video monitor receives the real-time image signal from Bronchoscope and displays the live image. During the bronchoscope sputum aspiration and collection, the fluid in the patient's body can be sucked out by pressing the suction button on the bronchoscope. The sampler control switch can collect liquid into the sampler.
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    K Number
    K241612
    Device Name
    Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
    Manufacturer
    Hunan Vathin Medical Instrument Co.Ltd
    Date Cleared
    2024-10-29

    (146 days)

    Product Code
    EOQ, EOO
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hunan Vathin Medical Instrument Co.Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single-use Flexible Bronchoscope has been designed to used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation. The Video Bronchoscope System is for use in professional Healthcare Facility Environment.
    Device Description
    The Video Bronchoscope System consists of a Single-use Flexible Bronchoscope to be introduced within the airways or tracheobronchial tree and a Digital Video Monitor for endoscopic image processing and displaying. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Digital Video Monitor receives, processes the real-time image signal from the endoscope and displays the live image on the screen. The Single-use Flexible Bronchoscope has six models: BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00. The main differences between product models are the size of the device channel, the color of the rotating sleeve, and whether it is self-locking.
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