Epidural Anesthesia Kit

What Is This Device?

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.

What Is FDA Product Code OGE?

Epidural Anesthesia Kit is FDA product code OGE, Class 2, 21 CFR 868.5120.

How Does It Reach the US Market?

The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.

What Do the Recalls Say?

The FDA has recorded 33 recalls under this product code since 2017. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Process control (21), Employee error (3) and Mixed-up of materials/components (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.