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510(k) Data Aggregation

    K Number
    K232295
    Device Name
    LAA Exclusion System
    Manufacturer
    Syntheon, LLC
    Date Cleared
    2023-08-30

    (29 days)

    Product Code
    PZX
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Syntheon, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.
    Device Description
    The LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm, 40mm, 45mm to accommodate different sizes of LAA. The LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.
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    K Number
    K220305
    Device Name
    Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
    Manufacturer
    Syntheon
    Date Cleared
    2022-10-28

    (268 days)

    Product Code
    PZX
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Syntheon

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.
    Device Description
    The Syntheon LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm. 40mm, 45mm, and 50mm to accommodate different sizes of LAA. The Syntheon LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.
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    K Number
    K080317
    Device Name
    ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
    Manufacturer
    SYNTHEON LLC
    Date Cleared
    2008-04-29

    (83 days)

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

    SYNTHEON LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoLok™ is indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy.
    Device Description
    The EndoLok™ is a non-sterile, single-use device designed to be used in conjunction with standard colonoscopes. It consists of a handle with a trigger mechanism that is used to grip the colonoscope shaft.
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