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510(k) Data Aggregation

    K Number
    K180650
    Device Name
    Amsel Endo Occluder
    Date Cleared
    2018-11-15

    (247 days)

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

    Amsel Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Amsel Endo Occluder device is an endoscopic ligating clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
    Device Description
    Amsel Endo Occluder device is an endoscopic ligating clip applier that is pre-loaded with four sterile ligating clips. Amsel Endo Occluder device is intended to be used during endoscopic procedures (such as Laparoscopic procedures), for permanent secure occlusion of blood vessels and ductal structures. The device is a mechanical occlusion clip that when deployed transfixes the target vessel while clamping it shut. Amsel Endo Occluder contains two main components: Ligating (Occluder) Clips and Applier (device delivery).
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    K Number
    K172479
    Device Name
    Amsel Occluder Device
    Manufacturer
    Date Cleared
    2017-09-14

    (29 days)

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

    Amsel Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
    Device Description
    Not Found
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    K Number
    K140932
    Device Name
    AMSEL OCCLUDER DEVICE
    Date Cleared
    2015-01-23

    (287 days)

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

    AMSEL MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
    Device Description
    The Amsel Occluder Device involves the implantation of a mechanical occlusion device that penetrates into and through the target vessel structure and when compressed and locked, clamps the vessel shut. The device consists of a metallic clip construct comprised of two compression components and an interlocking implant rod that when compressed together as a unit and locked on either side of a vessel results in occlusion. The delivery device consists of a hand held syringe-like device loaded with the components of the implant construct. The device is for use in general surgical procedures. Once positioned correctly, the occlusion construct is actuated through a series of semiautomatic steps resulting in the two components becoming compressed on either side of the vessel and locked together to occlude the vessel. Once occlusion is achieved, the delivery system, which is mechanically locked to the implant rod, is detached from the implant and the needle is withdrawn leaving the occlusion construct implanted, permanently occluding the vessel.
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