BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HORIZONS PAPILLOTOME

    K Number: K002236 · Decision Jan 23, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    10
    Review Days
    183

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    Basic Information

    Device Name
    HORIZONS PAPILLOTOME
    K Number
    K002236
    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
    July 24, 2000
    Decision Date
    January 23, 2001
    Product Code
    KNS
    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
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Horizons Intl. Corp.

    K Number Device Name
    K083049 TORNADO ROTATABEL SNARE AND POLYP CATCHER
    K022268 HORIZONS REUSABLE POLYPECTOMY SNARES
    K022243 HORIZONS REUSABLE HOT BIOPSY FORCEPS
    K022546 HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
    K021998 HORIZONS CYTOLOGY BRUSH
    K021706 HORIZONS HOT BIOPSY FORCEPS
    K011667 HORIZONS INTERNATIONAL POLYPECTOMY SNARES
    K010448 HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
    K002235 HORIZONS ERCP CANNULA