FDA product code OGV: Tracheostomy Cleaning Tray

OGV is the FDA product code for tracheostomy cleaning tray. It is a Class II device, regulated under 21 CFR 868.5800 and reviewed by the Ear, Nose and Throat panel. Devices under OGV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OGV devices, 1 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 OGV devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-10-16.

Frequently asked questions

What is FDA product code OGV?

OGV is the FDA product code for tracheostomy cleaning tray. It is a Class II device, regulated under 21 CFR 868.5800 and reviewed by the Ear, Nose and Throat panel.

What device class is OGV?

Class II, regulation 21 CFR 868.5800. Typical premarket route: 510(k) exempt.

Have OGV devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2023-10-16.

Next steps

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