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

    Standard Bougie, 38 Fr. and Hand Pump

    K Number: K212728 · Decision Sep 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    10
    Review Days
    27

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    Basic Information

    Device Name
    Standard Bougie, 38 Fr. and Hand Pump
    K Number
    K212728
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Standard Bariatrics
    Date Received
    August 27, 2021
    Decision Date
    September 23, 2021
    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 Standard Bariatrics

    K Number Device Name
    K210437 Standard Bougie, 38 Fr.
    K210278 Titan SGS
    K200517 Standard Trocar
    K191885 Standard Bougie
    K190788 Disposable Standard Clamp
    K181608 Disposable Standard Clamp
    K170379 Disposable Standard Clamp
    K161720 Standard Clamp
    K153358 Standard Clamp