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

    Sunny Cup and Applicator

    K Number: K233361 · Decision Jun 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    266

    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
    Sunny Cup and Applicator
    K Number
    K233361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5400
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Menstrual Mates
    Date Received
    September 29, 2023
    Decision Date
    June 21, 2024
    Product Code
    HHE
    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
    HHE Cup, Menstrual

    Similar 510(k) Clearances

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

    MELUNA CLASSIC/SPORT MENSTRUAL CUP

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

    FEMMYCYCLE

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

    SCKOONCUP

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

    RHEA CUP

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

    BELLECUP

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

    LUNETTE MENSTRUAL CUP, MODELS 1 AND 2

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