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

    STRYKER INFRAVISION ESOPHAGEAL KIT

    K Number: K983220 · Decision Jun 4, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    101
    Review Days
    263

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    Basic Information

    Device Name
    STRYKER INFRAVISION ESOPHAGEAL KIT
    K Number
    K983220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Endoscopy
    Date Received
    September 14, 1998
    Decision Date
    June 4, 1999
    Product Code
    FAT
    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
    FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

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