FDA product code OGE: Epidural Anesthesia Kit

OGE is the FDA product code for epidural anesthesia kit. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the Anesthesiology panel. Devices under OGE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 33 recalls for OGE devices, 30 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

Recalls for OGE devices

33 product recalls in 14 recall events; 30 initiated in the last five years and 29 still open. Most recent: 2026-06-17.

Frequently asked questions

What is FDA product code OGE?

OGE is the FDA product code for epidural anesthesia kit. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the Anesthesiology panel.

What device class is OGE?

Class II, regulation 21 CFR 868.5120. Typical premarket route: 510(k) exempt.

Have OGE devices been recalled?

Yes: 33 product recalls across 14 recall events; the most recent began 2026-06-17.

Next steps

• Run an FDA pathway report with predicate devices for product code OGE
• Run a recall and safety report across every OGE manufacturer
• Watch product code OGE 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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