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

    ENTACT SEPTAL STAPLER, MODEL 610-00100

    K Number: K082750 · Decision Jan 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    109

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    Basic Information

    Device Name
    ENTACT SEPTAL STAPLER, MODEL 610-00100
    K Number
    K082750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Entrigue Surgical, Inc.
    Date Received
    September 19, 2008
    Decision Date
    January 6, 2009
    Product Code
    OLL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OLL Septal Stapler/Absorbable Staples

    Other Clearances by Entrigue Surgical, Inc.

    K Number Device Name
    K130354 MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
    K121351 SINUS DILATION SYSTEM
    K072470 BIOELAST 5-0 SUTURE, MODEL 500100