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

    INFLATABLE RETENTION CUFF SPECULUM

    K Number: K941391 · Decision Oct 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    212

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    Basic Information

    Device Name
    INFLATABLE RETENTION CUFF SPECULUM
    K Number
    K941391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innovatec Medical Corp.
    Date Received
    March 22, 1994
    Decision Date
    October 20, 1994
    Product Code
    GBT
    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
    GBT Catheter, Rectal

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