FDA product code QRZ: External Condom For Anal Intercourse Or Vaginal Intercourse
QRZ is the FDA product code for external condom for anal intercourse or vaginal intercourse. It is a Class II device, regulated under 21 CFR 884.5305 and reviewed by the Obstetrics and Gynecology panel. Devices under QRZ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | External Condom For Anal Intercourse Or Vaginal Intercourse |
| Device class | Class II |
| Regulation | 21 CFR 884.5305 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Recalls for QRZ devices
openFDA lists no recalls for product code QRZ.
Frequently asked questions
What is FDA product code QRZ?
QRZ is the FDA product code for external condom for anal intercourse or vaginal intercourse. It is a Class II device, regulated under 21 CFR 884.5305 and reviewed by the Obstetrics and Gynecology panel.
What device class is QRZ?
Class II, regulation 21 CFR 884.5305. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QRZ
- Run a recall and safety report across every QRZ manufacturer
- Watch product code QRZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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