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

    INVOcell Intravaginal Culture System

    K Number: K222932 · Decision Jun 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    269

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    Basic Information

    Device Name
    INVOcell Intravaginal Culture System
    K Number
    K222932
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6165
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Invo Bioscience
    Date Received
    September 26, 2022
    Decision Date
    June 22, 2023
    Product Code
    OYO
    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
    OYO Culture, Intravaginal, Assisted Reproduction

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OYO), ordered by most recent decision date.

    INVOcell

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Invo Bioscience

    K Number Device Name
    DEN150008 INVOcell