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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇷 Costa Rica

    TORNADO ROTATABEL SNARE AND POLYP CATCHER

    K Number: K083049 · Decision Dec 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    62
    Applicant Total
    10
    Review Days
    70

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    Basic Information

    Device Name
    TORNADO ROTATABEL SNARE AND POLYP CATCHER
    K Number
    K083049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Horizons Intl. Corp.
    Date Received
    October 14, 2008
    Decision Date
    December 23, 2008
    Product Code
    FDI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FDI Snare, Flexible

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    Other Clearances by Horizons Intl. Corp.

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    K021998 HORIZONS CYTOLOGY BRUSH
    K021706 HORIZONS HOT BIOPSY FORCEPS
    K011667 HORIZONS INTERNATIONAL POLYPECTOMY SNARES
    K010448 HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
    K002235 HORIZONS ERCP CANNULA
    K002236 HORIZONS PAPILLOTOME