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510(k) Data Aggregation

    K Number
    K083049
    Device Name
    TORNADO ROTATABEL SNARE AND POLYP CATCHER
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2008-12-23

    (70 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HORIZONS INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Horizons Rotatabel Snare and Polyp Catcher TORNADO™ is intended to Electrosurgically Remove and collect Polyps from the Gastro Intestinal Tract Under Endoscopic Visualization.
    Device Description
    Not Found
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    K Number
    K022243
    Device Name
    HORIZONS REUSABLE HOT BIOPSY FORCEPS
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2002-10-25

    (105 days)

    Product Code
    KGE
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HORIZONS INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Horizons Reusable Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.
    Device Description
    Not Found
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    K Number
    K022268
    Device Name
    HORIZONS REUSABLE POLYPECTOMY SNARES
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2002-10-25

    (102 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HORIZONS INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Polypectomy Snares are used for cutting of polyps.
    Device Description
    Not Found
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    K Number
    K022546
    Device Name
    HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2002-08-12

    (11 days)

    Product Code
    EOQEOO
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    HORIZONS INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Horizons ANSO Transbronchial Aspiration Needle is intended to be used in the flexible endescope for submucosal aspiration biopsy of the bronchial tree.
    Device Description
    Not Found
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    K Number
    K021998
    Device Name
    HORIZONS CYTOLOGY BRUSH
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2002-07-12

    (23 days)

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

    HORIZONS INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Horizons Cytology Brush is intended to be used in the flexible endescope to collect cell sampling, or to perform surveillance cultures.
    Device Description
    Not Found
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    K Number
    K021706
    Device Name
    HORIZONS HOT BIOPSY FORCEPS
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2002-06-21

    (29 days)

    Product Code
    KGE
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HORIZONS INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Horizons Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.
    Device Description
    Not Found
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    K Number
    K011667
    Device Name
    HORIZONS INTERNATIONAL POLYPECTOMY SNARES
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2001-08-16

    (78 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HORIZONS INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HORIZONS POLYPECTOMY SNARES ARE INTENDED TO ELECTROSURGICALLY REMOVE POLYPS IN THE GI TRACT UNDER ENDOSCOPIC VISUALIZATION
    Device Description
    Not Found
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    K Number
    K010448
    Device Name
    HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2001-05-16

    (90 days)

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

    HORIZONS INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002235
    Device Name
    HORIZONS ERCP CANNULA
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2001-01-23

    (183 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    HORIZONS INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002236
    Device Name
    HORIZONS PAPILLOTOME
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2001-01-23

    (183 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HORIZONS INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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