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

    ENDO-EASE ENDOSCOPIC OVERTUBE

    K Number: K060235 · Decision Aug 4, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    19
    Applicant Total
    5
    Review Days
    186

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    Basic Information

    Device Name
    ENDO-EASE ENDOSCOPIC OVERTUBE
    K Number
    K060235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spirus Medical, Inc.
    Date Received
    January 30, 2006
    Decision Date
    August 4, 2006
    Product Code
    FDA
    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
    FDA Enteroscope And Accessories

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    Other Clearances by Spirus Medical, Inc.

    K Number Device Name
    K080050 SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
    K080042 SPIRUS MEDICAL SURGICAL INSTRUMENT
    K062805 MODIFICATION TO ENDO-EASE
    K052084 ENDO-EASE ENDOSCOPIC OVERTUBE