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

    HORIZONS HOT BIOPSY FORCEPS

    K Number: K021706 · Decision Jun 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    45
    Applicant Total
    10
    Review Days
    29

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    Basic Information

    Device Name
    HORIZONS HOT BIOPSY FORCEPS
    K Number
    K021706
    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
    May 23, 2002
    Decision Date
    June 21, 2002
    Product Code
    KGE
    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
    KGE Forceps, Biopsy, Electric

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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
    K011667 HORIZONS INTERNATIONAL POLYPECTOMY SNARES
    K010448 HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
    K002235 HORIZONS ERCP CANNULA
    K002236 HORIZONS PAPILLOTOME