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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

    K Number: K014002 · Decision Mar 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    31
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
    K Number
    K014002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fortune Medical Instrument Corp.
    Date Received
    December 4, 2001
    Decision Date
    March 4, 2002
    Product Code
    KOB
    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
    KOB Catheter, Suprapubic (And Accessories)

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