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

    WILTEK VARICES INJECTION NEEDLE

    K Number: K894868 · Decision Dec 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    21
    Review Days
    143

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    Basic Information

    Device Name
    WILTEK VARICES INJECTION NEEDLE
    K Number
    K894868
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Wiltek Medical, Inc.
    Date Received
    July 31, 1989
    Decision Date
    December 21, 1989
    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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    K914882 WILTEK BALLOON CHOLANGIOGRAPHY CATHETER
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    K914132 WILTEK ELECTROCAUTERY ACTIVE CORD
    K914131 WILTEK ELECTROCAUTERY ADAPTOR
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