BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Béa Applicator (BAP-GB-01)

    K Number: K242031 · Decision Apr 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    28
    Applicant Total
    1
    Review Days
    265

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Béa Applicator (BAP-GB-01)
    K Number
    K242031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stepone Fertility Ltd (T/A Béa Fertility)
    Date Received
    July 11, 2024
    Decision Date
    April 2, 2025
    Product Code
    HDR
    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
    HDR Cap, Cervical

    Similar 510(k) Clearances

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

    FERTI-LILY Conception Cup

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

    OVES CERVICAL CAP

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

    IMAGYN INTRAUTERINE INSEMINATION DEVICE

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

    COOK INSEMINATION CUP

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

    MINISPACE(TM) IUI CATHETER

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

    COAXIAL CATHETER SET

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