FDA product code OGW: Tracheostomy Kit
OGW is the FDA product code for tracheostomy kit. It is a Class II device, regulated under 21 CFR 868.5800 and reviewed by the Ear, Nose and Throat panel. Devices under OGW 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 | Tracheostomy Kit |
| Device class | Class II |
| Regulation | 21 CFR 868.5800 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Recalls for OGW devices
openFDA lists no recalls for product code OGW.
Frequently asked questions
What is FDA product code OGW?
OGW is the FDA product code for tracheostomy kit. It is a Class II device, regulated under 21 CFR 868.5800 and reviewed by the Ear, Nose and Throat panel.
What device class is OGW?
Class II, regulation 21 CFR 868.5800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OGW
- Run a recall and safety report across every OGW manufacturer
- Watch product code OGW 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.
All Ear, Nose and Throat product codes · FDA product code lookup