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510(k) Data Aggregation

    K Number
    K242927
    Device Name
    Suction Irrigation Tubing Set
    Manufacturer
    Date Cleared
    2024-11-22

    (59 days)

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

    Advamedix, GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Suction Irrigation Tubing Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation normal saline to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site to aid visualization.
    Device Description
    The Disposable Suction Irrigation Tubing Set consists of a grip body equipped with two trumpet style valves, a probe, and connecting lines of tubing; one set designed to attach a supply of irrigation normal saline, and the other designed to attach to suction equipment (aspiration pump). The valves allow for control of irrigation and aspiration during a surgical procedure. The handpiece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. The device is packaged as sterile with a shelf life of 3 years and is for single use only.
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    K Number
    K241052
    Device Name
    Bladeless Trocar; Bladed Trocar; Hasson Trocar
    Manufacturer
    Date Cleared
    2024-10-04

    (170 days)

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

    Advamedix, GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bladeless Trocar, Bladed Trocar, and Hasson Trocar have application in a variety of laparoscopic procedures to provide a port of entry for laparoscopic instruments.
    Device Description
    The Disposable Surgical Trocar is composed of two parts, one obturator and one guide tube (cannula). The obturator of the Bladeless Trocar is plastic allowing the surgeon to dilate between tissues. The obturator of Bladed Trocar is made of PC and a small blade made of stainless steel, which is released when the surgeon presses the trocar to help with cutting. The Disposable Surgical Trocar Kit, bladed or bladeless, has one obturator and two cannulas or two obturators and four cannulas. The device is for single use only. This device is sterilized with ethylene oxide and has a shelf life of 3 years.
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