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

    MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

    K Number: K021034 · Decision Jun 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    4
    Review Days
    89

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    Basic Information

    Device Name
    MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
    K Number
    K021034
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tfx Medical, Inc.
    Date Received
    March 29, 2002
    Decision Date
    June 26, 2002
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Tfx Medical, Inc.

    K Number Device Name
    K020985 MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
    K000665 TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
    K993191 TFX MEDICAL INTRODUCER ASSEMBLY