FDA product code QHZ: Seal, Cervical, Mechanical, Unpowered
QHZ is the FDA product code for seal, cervical, mechanical, unpowered. It is a Class I device, regulated under 21 CFR 884.1690 and reviewed by the Obstetrics and Gynecology panel. Devices under QHZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Reduce fluid leakage from the cervix during hysteroscopic procedures.
Classification
| Field | Value |
|---|---|
| Device name | Seal, Cervical, Mechanical, Unpowered |
| Device class | Class I |
| Regulation | 21 CFR 884.1690 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for QHZ devices
openFDA lists no recalls for product code QHZ.
Frequently asked questions
What is FDA product code QHZ?
QHZ is the FDA product code for seal, cervical, mechanical, unpowered. It is a Class I device, regulated under 21 CFR 884.1690 and reviewed by the Obstetrics and Gynecology panel.
What device class is QHZ?
Class I, regulation 21 CFR 884.1690. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QHZ
- Run a recall and safety report across every QHZ manufacturer
- Watch product code QHZ 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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