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

    TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE

    K Number: K935834 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    42
    Applicant Total
    3
    Review Days
    90

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    Basic Information

    Device Name
    TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE
    K Number
    K935834
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Technology Marketing Group
    Date Received
    December 7, 1993
    Decision Date
    March 7, 1994
    Product Code
    FBN
    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
    FBN Choledochoscope And Accessories, Flexible/Rigid

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    Other Clearances by Technology Marketing Group

    K Number Device Name
    K941715 ULTATHIN FLEXIBLE ENDOSCOPE
    K942388 TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE