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

    NOETIX, BIOPSY NEEDLE

    K Number: K893992 · Decision Sep 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    3
    Review Days
    95

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    Basic Information

    Device Name
    NOETIX, BIOPSY NEEDLE
    K Number
    K893992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Noetix, Inc.
    Date Received
    June 5, 1989
    Decision Date
    September 8, 1989
    Product Code
    KNW
    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
    KNW Instrument, Biopsy

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    Other Clearances by Noetix, Inc.

    K Number Device Name
    K881635 NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM
    K871365 CAPSULECTOMER CYSTOTOME