BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    NeedleSmart Professional (NS Pro)

    K Number: K202073 · Decision Mar 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    241

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    Basic Information

    Device Name
    NeedleSmart Professional (NS Pro)
    K Number
    K202073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6210
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Needlesmart Limited
    Date Received
    July 27, 2020
    Decision Date
    March 25, 2021
    Product Code
    MTV
    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
    MTV Sharps Needle Destruction Device