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510(k) Data Aggregation

    K Number
    K232703
    Device Name
    Disposable Bipolar Forceps
    Date Cleared
    2024-03-06

    (183 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Hope Biomedical Science&Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.
    Device Description
    Disposable Bipolar Forceps consists of forceps pieces, forceps holder, wire. The tail end of the forceps pieces are connected with the forceps holder. The forceps holder is provided with a high frequency input wire, and the wire can be connected with the high frequency surgical equipment through a plug. The outer surface of the forceps pieces are provided with an insulation layer. Disposable Bipolar Forceps materials: forceps tips material: silver plated brass; forceps pieces material: brass; forceps pieces coating: epoxy resin; packaging: PETG tray, Tyvek lid. The structure of Disposable Bipolar Forceps is double forceps pieces. Two fingers pinch the left and right forceps pieces, so that the forceps tips gently clamp the tissues, through the high frequency current to achieve electrocoagulation hemostasis. The rebound action is realized by the rebound force of the forceps pieces.
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    K Number
    K231615
    Device Name
    Disposable Endoscopic Bipolar
    Date Cleared
    2023-12-05

    (186 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Hope Biomedical Science & Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable Endoscopic Bipolar is a sterile, single use electrosurgical instrument intended to conduct electrosurgical current for coagulation of tissue during general surgical procedures.
    Device Description
    Disposable endoscopic bipolar consists of electrode, power line, socket, handle group, inner rod, pushrod. Handle group consists of block, set screw, handle, fixed block, rivet pin, rivet cap, connecting rod, sliding block, spring, front insert, upper cover, lower cover, tail sleeve. The inner rod is set in the pushrod and handle group mechanism, and is fixed with set screws and fixed block, and the pushrod is connected to the sliding block. The back end of the push rod is shaped like a semi-circle for easy bending and use. The product is divided in straight and curved based on poshrod shape type. The electrodes are equipped with the insulating sleeve, and the outer side of the sleeve is provided with a stainless steel armor plate to prevent the push rod from rubbing the sleeve. The electrodes are fixed in the inner rod. The electrodes are connected to the socket through power line, and the socket can be connected to the high frequency surgical equipment. Disposable endoscopic bipolar materials: Stainless Steel, Plastic Material.
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