FDA product code OGS: Myringotomy Procedure Kit

OGS is the FDA product code for myringotomy procedure kit. It is a Class II device, regulated under 21 CFR 874.3880 and reviewed by the Ear, Nose and Throat panel. Devices under OGS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OGS 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 OGS devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-17.

Frequently asked questions

What is FDA product code OGS?

OGS is the FDA product code for myringotomy procedure kit. It is a Class II device, regulated under 21 CFR 874.3880 and reviewed by the Ear, Nose and Throat panel.

What device class is OGS?

Class II, regulation 21 CFR 874.3880. Typical premarket route: 510(k) exempt.

Have OGS devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2022-11-17.

Next steps

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