FDA product code HHQ: System, Abortion, Metreurynter-Balloon
HHQ is the FDA product code for system, abortion, metreurynter-balloon. It is a Class III device, regulated under 21 CFR 884.5050 and reviewed by the Obstetrics and Gynecology panel. Devices under HHQ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | System, Abortion, Metreurynter-Balloon |
| Device class | Class III |
| Regulation | 21 CFR 884.5050 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for HHQ devices
openFDA lists no recalls for product code HHQ.
Frequently asked questions
What is FDA product code HHQ?
HHQ is the FDA product code for system, abortion, metreurynter-balloon. It is a Class III device, regulated under 21 CFR 884.5050 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHQ?
Class III, regulation 21 CFR 884.5050. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HHQ
- Run a recall and safety report across every HHQ manufacturer
- Watch product code HHQ 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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