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510(k) Data Aggregation

    K Number
    K243482
    Device Name
    Self-Forming Magnet (Flexagon)
    Manufacturer
    GI Windows Inc.
    Date Cleared
    2025-06-11

    (215 days)

    Product Code
    SAH
    Regulation Number
    878.4816
    Why did this record match?
    Applicant Name (Manufacturer) :

    GI Windows Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GI Windows FLEXAGON System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows FLEXAGON is intended for use in adult patients > 21 years.
    Device Description
    The FLEXAGON device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive surgery in the gastrointestinal tract. The system is comprised of magnets and includes the delivery systems. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with subsequent healing of tissue around the devices. Once the anastomosis is formed the magnet device is expelled naturally in approximately 3-6 weeks.
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    K Number
    K243213
    Device Name
    Self-Forming Magnet (FLEX SFM)
    Manufacturer
    GI Windows Inc.
    Date Cleared
    2025-01-29

    (118 days)

    Product Code
    SAH
    Regulation Number
    878.4816
    Why did this record match?
    Applicant Name (Manufacturer) :

    GI Windows Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GI Windows FLEX SFM System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows FLEX SFM is intended for use in adult patients > 21 years.
    Device Description
    The FLEX SFM device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The systems are comprised of magnet devices and include delivery systems. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with healing of tissue around the devices. Once the anastomosis is formed, the magnet devices are expelled naturally (within 3-6 weeks).
    Ask a Question

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