FDA product code OGQ: Ear Irrigation Kit
OGQ is the FDA product code for ear irrigation kit. It is a Class I device, regulated under 21 CFR 880.6960 and reviewed by the Ear, Nose and Throat panel. Devices under OGQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Classification
| Field | Value |
|---|---|
| Device name | Ear Irrigation Kit |
| Device class | Class I |
| Regulation | 21 CFR 880.6960 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for OGQ devices
openFDA lists no recalls for product code OGQ.
Frequently asked questions
What is FDA product code OGQ?
OGQ is the FDA product code for ear irrigation kit. It is a Class I device, regulated under 21 CFR 880.6960 and reviewed by the Ear, Nose and Throat panel.
What device class is OGQ?
Class I, regulation 21 CFR 880.6960. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OGQ
- Run a recall and safety report across every OGQ manufacturer
- Watch product code OGQ 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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