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510(k) Data Aggregation

    K Number
    K250389
    Device Name
    XNY Disposable Gastric Calibration Tube
    Manufacturer
    Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.
    Date Cleared
    2025-04-10

    (58 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XNY Disposable Gastric Calibration Tube is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.
    Device Description
    The XNY Disposable Gastric Calibration Tubes are indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch. The device has the advantages of accurately determining residual gastric capacity and easy positioning, and it can be connected to a suction device to extract the gas or liquid in the patient's stomach.
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    K Number
    K190029
    Device Name
    Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
    Manufacturer
    Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.
    Date Cleared
    2019-09-26

    (262 days)

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

    Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
    Device Description
    The proposed devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, are basic equipment used during laparoscopic surgical, which consist of Puncture Needle, Puncture Sleeve, Injection Valve, Cap and Safety lock. They are available in multiple configurations, including bladed type, bladeless type and optical type. In order to obtain access to the surgical site during laparoscopic surgery, the Puncture Needle is introduced into Puncture Sleeve to accomplish cannula penetration of the abdominal wall. The sleeve is connected to the Injection Valve at its proximal end and once the abdominal/thoracic wall is punctured, the puncture needle is removed. The sleeve acts as a channel for the introduction of the endoscopes and instruments. Generically, puncture needle and sleeve are available in a range of lengths and diameters to accommodate different sizes surgical instrument
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