FDA product code OGF: Glossopharyngeal Anesthesia Kit
OGF is the FDA product code for glossopharyngeal anesthesia kit. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the Anesthesiology panel. Devices under OGF 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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Classification
| Field | Value |
|---|---|
| Device name | Glossopharyngeal Anesthesia Kit |
| Device class | Class II |
| Regulation | 21 CFR 868.5120 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Recalls for OGF devices
openFDA lists no recalls for product code OGF.
Frequently asked questions
What is FDA product code OGF?
OGF is the FDA product code for glossopharyngeal anesthesia kit. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the Anesthesiology panel.
What device class is OGF?
Class II, regulation 21 CFR 868.5120. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OGF
- Run a recall and safety report across every OGF manufacturer
- Watch product code OGF 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.