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

    Sterile Auto-Disable Syringes with/without Needle for Single Use

    K Number: K211210 · Decision Jan 27, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    4
    Review Days
    279

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    Basic Information

    Device Name
    Sterile Auto-Disable Syringes with/without Needle for Single Use
    K Number
    K211210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Azur Medical Company, Inc.
    Date Received
    April 23, 2021
    Decision Date
    January 27, 2022
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Azur Medical Company, Inc.

    K Number Device Name
    K231719 Medical Surgical Mask
    K211214 Sterile Hypodermic Needles for Single Use
    K211211 Sterile syringes for single use with/without needle