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510(k) Data Aggregation

    K Number
    K232866
    Device Name
    Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
    Date Cleared
    2023-11-07

    (53 days)

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

    Jiangsu Channel Medical Device Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) is used to puncture the abdominal wall of human body during laparoscopy and operation to establish the working channel for abdominal surgery.
    Device Description
    The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) are available in total of eight (8) sizes. The Disposable Abdominal Trocars (Bladed Trocars), knows as Auto-Locking Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Disposable Abdominal Trocars (Bladed Trocars) is available in three (3) sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The Disposable Abdominal Trocars (Bladeless Trocars) has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Disposable Abdominal Trocars (Bladeless Trocars) is available in one (1) size: 5mm. The Disposable Abdominal Trocars (Optical Trocars), knows as Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip, which is designed for open Laparoscopy. The Disposable Abdominal Trocars (Optical Trocars) is available in four (4) sizes: 5mm, 10mm, 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock. Based on the filter valve, the Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) are divided into two (2) product series: CNTCI series without smoke evacuation function and CNTCII series with smoke evacuation. The cannula consists of sleeve, stopcock valve, valve lever, gas check valve and lip seal. The obturator consists of fixed base, obturator tube and obturator tip. There are various specifications available depending on the inner diameter and length of sleeve.
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