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

    VR101 Lubricating Intravaginal Ring

    K Number: K203377 · Decision May 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    184

    Basic Information

    Device Name
    VR101 Lubricating Intravaginal Ring
    K Number
    K203377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J3 Bioscience, Inc.
    Date Received
    November 17, 2020
    Decision Date
    May 20, 2021
    Product Code
    QPD
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QPD Personal Lubricant Ring