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

    Visby Medical Women's Sexual Health Test

    K Number: DEN240020 · Decision Mar 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    319

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    Basic Information

    Device Name
    Visby Medical Women's Sexual Health Test
    K Number
    DEN240020
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3386
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Visby Medical, Inc.
    Date Received
    May 13, 2024
    Decision Date
    March 28, 2025
    Product Code
    SEA
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SEA Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

    Other Clearances by Visby Medical, Inc.

    K Number Device Name
    K253971 Visby Medical Flu and COVID-19 Test
    K251501 Visby Medical Men's Sexual Health Test
    K242526 Visby Medical Respiratory Health Test