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510(k) Data Aggregation

    K Number
    K242679
    Device Name
    Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)
    Manufacturer
    Fengh Medical Co., Ltd.
    Date Cleared
    2024-10-04

    (28 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fengh Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K202467
    Device Name
    Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
    Manufacturer
    Fengh Medical Co., Ltd.
    Date Cleared
    2020-12-14

    (109 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fengh Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
    Device Description
    The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are sterile. single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The Power Stapler and Reloads are sterilized by irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact (192±20mm), regular (252±20mm) and long (352±20mm). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.
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    K Number
    K182476
    Device Name
    Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
    Manufacturer
    Fengh Medical Co., Ltd.
    Date Cleared
    2019-12-18

    (464 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fengh Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Powered Articulating Endosopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
    Device Description
    The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The Power Stapler and Reloads are sterilized by irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact (192±20mm), regular (252±20mm) and long (352±20mm). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.
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    K Number
    K180208
    Device Name
    Disposable Endoscopic Trocar
    Manufacturer
    Fengh Medical Co., Ltd.
    Date Cleared
    2018-04-09

    (75 days)

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

    Fengh Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Endoscopic Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
    Device Description
    The Fengh Medical Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. A Disposable Endoscopic Trocar is mainly composed of Obturator Handle, Outer Seal Release Lever. Trocar Stability Sleeve, Obturator Locking Button, Trocar Stability Sleeve, etc. Materials being used include Stainless 12Cr18Ni9, Stainless 06Cr19Ni10, ABS plastic, PC. All the components of Disposable Endoscopic Trocar are evaluated by cytotoxicity test, sensitization test, intracutaneous mucosa stimulation test, Systemic toxicity(acute) test and Pyrogenicity test. Therefore, it will not cause bad stimulations, allergic reactions or other harm to human tissue or mucosa. Furthermore, no toxic substances will be separated out during the use of Disposable Endoscopic Trocar. Endoscopic surgery is conducted through a cannula that extends across the abdominal wall and provides channels where instruments, such as scopes, retractors and staplers, can be inserted to perform surgery. As part of this procedure, the abdominal cavity is inflated with an insufflation gas, such carbon dioxide, to maintain the abdomen in a distended state and provide increased instrument maneuvering capability within the cavity. Valves are typically provided in the trocars to form seals around the instruments to prevent leakage of the insufflation gas.
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