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

    ENDOTINE RIBBON

    K Number: K050611 · Decision Apr 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    17
    Review Days
    28

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    Basic Information

    Device Name
    ENDOTINE RIBBON
    K Number
    K050611
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coapt Systems, Inc.
    Date Received
    March 9, 2005
    Decision Date
    April 6, 2005
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Coapt Systems, Inc.

    K Number Device Name
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    K060249 ULTRATINE FOREHEAD
    K060248 ULTRATINE TRANSBLEPH
    K060828 MODIFICATION TO ENDOTINE RIBBON
    K051415 ENDOTINE RIBBON
    K042796 ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
    K041835 ENDOTINE MIDFACE B 4.5 DEVICE
    K042078 ENDOTINE FOREHEAD TRIPLE DEVICE
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