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510(k) Data Aggregation

    K Number
    K984255
    Device Name
    OLYMPUS HX-20 SERIES LIGATING DEVICE
    Date Cleared
    1999-01-12

    (43 days)

    Product Code
    Regulation Number
    876.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLYMPUS CORP OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Olympus HX-20-1 Endoscopic Ligator "EndoLoop" has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Ligation Loop(Standard) or MAJ-340 Ligation Loop (Small) designed to prevent or control bleeding following polypectompy of pedunculated polyps.
    Device Description
    The Olympus HX-20-1 Endoscopic Ligator is intended to deliver a MAJ-254 Ligation Loop (Standard) or MAJ-340 Ligation Loop (Small ) to prevent or control bleeding following polypectomy of pedunculated polyps. The Olympus HX-20-1 Endoscopic Ligator "EndoLoop" is substantially equivalent in intended use to the Olympus HX-20-1 which has been cleared premarket notification with #K964661. The modification on this submission differs from previously cleared 510(k) HX-20-1 in the instruction manual with emergency treatments and warnings.
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