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510(k) Data Aggregation

    K Number
    K040148
    Device Name
    RESOLUTION HEMOSTASIS CLIPPING DEVICE
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2004-04-22

    (90 days)

    Product Code
    MCH, FHN, MND
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    MCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: endoscopic marking; hemostasis for mucosal/submucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm in diameter, diverticula in the colon; anchoring to affix jejunal feeding tubes to the wall of the small bowel; as a supplemental closure method of luminal perforations <20mm that can be treated conservatively.
    Device Description
    The ResolutionTM Hemostasis Clipping Device is a single-use pre-loaded mechanical clip and delivery system used for endoscopic clipping.
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    K Number
    K972745
    Device Name
    TITANIUM HEMOSTATIC CLIP
    Manufacturer
    EISNER USA, INC.
    Date Cleared
    1997-10-21

    (90 days)

    Product Code
    MCH
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    MCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EISNER USA Hemostatic Clip is designed for the intended use of ligating blood vessels. The clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The Clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary.
    Device Description
    The clips are composed exclusively of titanium and are supplied sterile in various sizes (small, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I.
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