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

    HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES

    K Number: K022546 · Decision Aug 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    10
    Review Days
    11

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    Basic Information

    Device Name
    HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
    K Number
    K022546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Horizons Intl. Corp.
    Date Received
    August 1, 2002
    Decision Date
    August 12, 2002
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by Horizons Intl. Corp.

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    K022243 HORIZONS REUSABLE HOT BIOPSY FORCEPS
    K021998 HORIZONS CYTOLOGY BRUSH
    K021706 HORIZONS HOT BIOPSY FORCEPS
    K011667 HORIZONS INTERNATIONAL POLYPECTOMY SNARES
    K010448 HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
    K002235 HORIZONS ERCP CANNULA
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