FDA product code OGR: Ear, Nose, And Throat Surgical Tray

OGR is the FDA product code for ear, nose, and throat surgical tray. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. Devices under OGR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 76 recalls for OGR devices, 56 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 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

Recalls for OGR devices

76 product recalls in 63 recall events; 56 initiated in the last five years and 54 still open. Most recent: 2026-08-10.

Frequently asked questions

What is FDA product code OGR?

OGR is the FDA product code for ear, nose, and throat surgical tray. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.

What device class is OGR?

Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.

Have OGR devices been recalled?

Yes: 76 product recalls across 63 recall events; the most recent began 2026-08-10.

Next steps

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