BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Artiglass NRFitTM Tip L.O.R. Glass Syringes

    K Number: K213800 · Decision May 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    164

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    Basic Information

    Device Name
    Artiglass NRFitTM Tip L.O.R. Glass Syringes
    K Number
    K213800
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Artiglass Srl
    Date Received
    December 6, 2021
    Decision Date
    May 19, 2022
    Product Code
    QEH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

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    Other Clearances by Artiglass Srl

    K Number Device Name
    K122416 ARTIGLASS L. O.R. GLASS SYRINGE