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

    Lucy Breast Pump

    K Number: K213311 · Decision Feb 9, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    2
    Review Days
    128

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    Basic Information

    Device Name
    Lucy Breast Pump
    K Number
    K213311
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Willow Innovations, Inc.
    Date Received
    October 4, 2021
    Decision Date
    February 9, 2022
    Product Code
    HGX
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    HGX Pump, Breast, Powered

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    Other Clearances by Willow Innovations, Inc.

    K Number Device Name
    K230570 Willow Generation 3 Breast Pump