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

    Removal System Large Bore 60 cc Syringe

    K Number: K233069 · Decision Mar 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    30
    Review Days
    182

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    Basic Information

    Device Name
    Removal System Large Bore 60 cc Syringe
    K Number
    K233069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inari Medical, Inc.
    Date Received
    September 26, 2023
    Decision Date
    March 26, 2024
    Product Code
    PUR
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PUR Vacuum Syringe

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