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

    SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE

    K Number: K901429 · Decision Jun 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    42
    Applicant Total
    22
    Review Days
    71

    Basic Information

    Device Name
    SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE
    K Number
    K901429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    TELEMED SYSTEMS, INC.
    Date Received
    March 26, 1990
    Decision Date
    June 5, 1990
    Product Code
    OCY
    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
    OCY Endoscopic Guidewire, Gastroenterology-Urology

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