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

    SINUS DILATION SYSTEM

    K Number: K121351 · Decision Aug 29, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    223
    Registration Numbers
    223
    Same Product Code
    64
    Applicant Total
    4
    Review Days
    117

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    Basic Information

    Device Name
    SINUS DILATION SYSTEM
    K Number
    K121351
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Entrigue Surgical, Inc.
    Date Received
    May 4, 2012
    Decision Date
    August 29, 2012
    Product Code
    LRC
    Advisory Committee
    Ear, Nose, Throat
    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
    LRC Instrument, Ent Manual Surgical

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    Other Clearances by Entrigue Surgical, Inc.

    K Number Device Name
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    K072470 BIOELAST 5-0 SUTURE, MODEL 500100