BEUDAMED
    Product Code: QRZ FDA class 2 21 CFR 884.5305

    External Condom For Anal Intercourse Or Vaginal Intercourse

    Obstetrics/Gynecology

    The External Condom for Anal Intercourse or Vaginal Intercourse is a barrier contraceptive and infection-prevention device that covers the penis during anal or vaginal intercourse to prevent transmission of sexually transmitted infections and, when used for vaginal intercourse, to provide contraception. This classification specifically covers condoms intended for both types of intercourse, distinguishing it from classifications limited to vaginal intercourse only. Classified as FDA Class 2 under regulation 884.5305, it requires 510(k) clearance in the Obstetrics and Gynecology specialty. It is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    QRZ
    Device Class
    FDA class 2
    Regulation Number
    884.5305
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An external condom for anal intercourse or vaginal intercourse is a barrier device which covers the penis and is used to prevent the transmission of sexually transmitted infections (when used for anal intercourse or vaginal intercourse) and for contraception (when used for vaginal intercourse). This classification does not include condoms intended for vaginal intercourse only.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN210034 ONE Male Condom

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.