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510(k) Data Aggregation

    K Number
    K222210
    Device Name
    AEON Endoscopic Stapler
    Manufacturer
    Lexington Medical Inc.
    Date Cleared
    2023-04-21

    (270 days)

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

    Lexington Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, thoracic and urologic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.
    Device Description
    The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload. This 510(k) revises the labeling, including indications, contraindications, and warnings, for the AEON Endoscopic Stapler.
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    K Number
    K201882
    Device Name
    AEON Endoscopic Stapler
    Manufacturer
    Lexington Medical Inc.
    Date Cleared
    2020-10-09

    (93 days)

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

    Lexington Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses
    Device Description
    The AEON™ Endoscopic Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples and staple line length are based on the selection of the Stapler Reload open staple height and staple line length. The AEON™ Endoscopic Stapler handle and reload are sterile, single use devices. The modification presented in this 510(k) is to remove the "MR Unsafe" from the MRI Safety Information section of the Instructions for Use (IFU).
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    K Number
    K180114
    Device Name
    AEON Retrieval Bag
    Manufacturer
    Lexington Medical Inc.
    Date Cleared
    2018-03-27

    (70 days)

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

    Lexington Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AEON™ Retrieval Bag is a sterile single use device that can be used for the encapture and removal of an organ, tissue, or fluid from the body cavity during laparoscopic surgery.
    Device Description
    The AEON™ Retrieval Bag, is a sterile, disposable, single-use, individually-packaged polymeric sack with laparoscopic introducer system that is designed to facilitate the removal of tissues or organs in the process of laparoscopic surgery. The system consists of a sack connected to a laparoscopic introducer system. The introducer system comprises an elongated rod for laparoscopic insertion, flexible arms to allow deployment of the sack in the surgical cavity, and a drawstring to facilitate sack closure and extraction.
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    K Number
    K173443
    Device Name
    AEON Endoscopic Stapler
    Manufacturer
    Lexington Medical Inc.
    Date Cleared
    2018-02-01

    (87 days)

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

    Lexington Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.
    Device Description
    The AEON™ Endoscopic Stapler places two. triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples is determined by the selection of the appropriate reload. This 510(k) reports reloads with two staple sizes (gray - 2.25mm and black - 5.0mm) and in two lengths (45mm and 60mm).
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    K Number
    K171589
    Device Name
    AEON Endoscopic Stapler
    Manufacturer
    Lexington Medical Inc.
    Date Cleared
    2017-11-17

    (170 days)

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

    Lexington Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.
    Device Description
    The AEON™ Endoscopic Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples is determined by the selection of the appropriate reload that is available in two staple sizes (tan - 3.25mm, purple - 4.0mm) and in one length (60mm).
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