FDA product code HIQ: Electrode, Clip, Fetal Scalp (And Applicator)
HIQ is the FDA product code for electrode, clip, fetal scalp (and applicator). It is a Class III device, regulated under 21 CFR 884.2685 and reviewed by the Obstetrics and Gynecology panel. Devices under HIQ 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 50708 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Clip, Fetal Scalp (And Applicator) |
| Device class | Class III |
| Regulation | 21 CFR 884.2685 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for HIQ devices
openFDA lists no recalls for product code HIQ.
Frequently asked questions
What is FDA product code HIQ?
HIQ is the FDA product code for electrode, clip, fetal scalp (and applicator). It is a Class III device, regulated under 21 CFR 884.2685 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIQ?
Class III, regulation 21 CFR 884.2685. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HIQ
- Run a recall and safety report across every HIQ manufacturer
- Watch product code HIQ 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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