BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EXPRESSAIRE TORUNIQUET SYSTEM

    K Number: K955552 · Decision Jan 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    107
    Registration Numbers
    107
    Same Product Code
    33
    Applicant Total
    87
    Review Days
    31

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    Basic Information

    Device Name
    EXPRESSAIRE TORUNIQUET SYSTEM
    K Number
    K955552
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5910
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    December 5, 1995
    Decision Date
    January 5, 1996
    Product Code
    KCY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KCY Tourniquet, Pneumatic

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    K963486 REVISION HIP SYSTEM
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