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

    VARICES INJECTION NEEDLE

    K Number: K012977 · Decision Nov 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    7
    Review Days
    58

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    Basic Information

    Device Name
    VARICES INJECTION NEEDLE
    K Number
    K012977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Endo-Therapeutics, Inc.
    Date Received
    September 5, 2001
    Decision Date
    November 2, 2001
    Product Code
    FBK
    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
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

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