FDA product code OGH: Laryngoscope Kit
OGH is the FDA product code for laryngoscope kit. It is a Class I device, regulated under 21 CFR 868.5540 and reviewed by the Anesthesiology panel. Devices under OGH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 4 recalls for OGH devices, 2 initiated in the last five years.
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 | Laryngoscope Kit |
| Device class | Class I |
| Regulation | 21 CFR 868.5540 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Recalls for OGH devices
4 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-11-08.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code OGH?
OGH is the FDA product code for laryngoscope kit. It is a Class I device, regulated under 21 CFR 868.5540 and reviewed by the Anesthesiology panel.
What device class is OGH?
Class I, regulation 21 CFR 868.5540. Typical premarket route: 510(k) exempt.
Have OGH devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2024-11-08.
Next steps
- Run an FDA pathway report with predicate devices for product code OGH
- Run a recall and safety report across every OGH manufacturer
- Watch product code OGH 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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