FDA product code OGJ: Nerve Block Tray

OGJ is the FDA product code for nerve block tray. It is a Class II device, regulated under 21 CFR 868.5140 and reviewed by the Anesthesiology panel. Devices under OGJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 46 recalls for OGJ devices, 43 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 OGJ devices

46 product recalls in 20 recall events; 43 initiated in the last five years and 18 still open. Most recent: 2026-07-23.

Frequently asked questions

What is FDA product code OGJ?

OGJ is the FDA product code for nerve block tray. It is a Class II device, regulated under 21 CFR 868.5140 and reviewed by the Anesthesiology panel.

What device class is OGJ?

Class II, regulation 21 CFR 868.5140. Typical premarket route: 510(k) exempt.

Have OGJ devices been recalled?

Yes: 46 product recalls across 20 recall events; the most recent began 2026-07-23.

Next steps

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