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510(k) Data Aggregation

    K Number
    K181690
    Device Name
    Clear-Jet Injection Catheter
    Manufacturer
    Finemedix Co. Ltd.
    Date Cleared
    2018-12-21

    (178 days)

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

    Finemedix Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clear-Jet Injection Catheter is to be used in conjunction with an endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
    Device Description
    Clear-Jet Injection Catheter consists of a stainless-steel needle attached to inner tube, an Injector Head attached to Catheter tube, and Slider where a standard syringe can be attached for injection of solutions through the lumen of the needle into tissue. It is available in various sizes and working lengths. The needle sizes are 21 gauge (outer diameter 0.8mm) and 23 gauge (outer diameter 0.6mm), and the needle lengths are 4.0mm and 6.0mm. The needle wall thicknesses are 0.1mm, 0.05mm, and the Catheter Tube length (=Working length) includes 1,800mm, 2,300mm. There are two types of Clear-Jet Injection Catheter such as Head type and Non-head type has the Injector Head made of stainless steel alloys attached to the Catheter Tube, Non -head type does not have the Injector Head made of stainless steel alloys. This device passes through the working channel of endoscope, and the average contact time with mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
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    K Number
    K180363
    Device Name
    Clear-Tip EUS-FNA
    Manufacturer
    Finemedix Co. Ltd.
    Date Cleared
    2018-11-01

    (265 days)

    Product Code
    FCG
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Finemedix Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clear-Tip EUS-FNA is used with an ultrasound endoscope for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.
    Device Description
    Clear-Tip EUS-FNA is used in conjunction with an ultrasound endoscope. It consists of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port. The insertion is composed of the Catheter Tube, Needle, and Stylet. A Syringe is attached to the aspiration port on the handle section to aspirate that was punctured with the Needle. Syringe and Stopcock are accessories to provide and control the vacuum suction to aspirate the tissue specimen. They also can be used to expel the samples after the procedure. Clear-Tip EUS-FNA is offered in various needle gauges for insertion. The available needle gauge sizes of 19, 22 and 25 gauges. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the Catheter Tube and Needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a Stylet to aid in inserting the Needle which is removed for injection and aspiration. This device passes through the working channel of endoscope, and the average contact time with mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized. This device is for Rx used only.
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