FDA product code OFU: Spinal Anesthesia Kit
OFU is the FDA product code for spinal anesthesia kit. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the Anesthesiology panel. Devices under OFU 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 | Spinal 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 OFU devices
openFDA lists no recalls for product code OFU.
Frequently asked questions
What is FDA product code OFU?
OFU is the FDA product code for spinal anesthesia kit. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the Anesthesiology panel.
What device class is OFU?
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 OFU
- Run a recall and safety report across every OFU manufacturer
- Watch product code OFU 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.