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

    OMNI Surgical System

    K Number: K173332 · Decision Dec 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    18
    Applicant Total
    8
    Review Days
    59

    Basic Information

    Device Name
    OMNI Surgical System
    K Number
    K173332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sight Sciences, Inc.
    Date Received
    October 23, 2017
    Decision Date
    December 21, 2017
    Product Code
    MRH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MRH Pump, Infusion, Ophthalmic

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