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

    Insignis Subcutaneous Needle Sets

    K Number: K202279 · Decision Aug 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    437
    Registration Numbers
    437
    Same Product Code
    1167
    Applicant Total
    2
    Review Days
    367

    Basic Information

    Device Name
    Insignis Subcutaneous Needle Sets
    K Number
    K202279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovative Health Sciences, LLC
    Date Received
    August 11, 2020
    Decision Date
    August 13, 2021
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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