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

    TISSUE SAMPLING NEEDLE

    K Number: K103694 · Decision Jul 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    94
    Review Days
    222

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    Basic Information

    Device Name
    TISSUE SAMPLING NEEDLE
    K Number
    K103694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    United States Endoscopy Group, Inc.
    Date Received
    December 17, 2010
    Decision Date
    July 27, 2011
    Product Code
    FCG
    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
    FCG Biopsy Needle

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