BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    MODIFICATION TO ENDOFAST RELIANT SYSTEM

    K Number: K080836 · Decision Apr 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    MODIFICATION TO ENDOFAST RELIANT SYSTEM
    K Number
    K080836
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endogun Medical Systems
    Date Received
    March 25, 2008
    Decision Date
    April 21, 2008
    Product Code
    FTL
    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
    FTL Mesh, Surgical, Polymeric

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    Other Clearances by Endogun Medical Systems

    K Number Device Name
    K060329 ENDOFAST RELIANT SYSTEM