FDA product code ETK: Tube, Toynbee Diagnostic

ETK is the FDA product code for tube, toynbee diagnostic. It is a Class I device, regulated under 21 CFR 874.1925 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under ETK. The average 510(k) review took 34 days (median 34).

Classification

Compare with all 510(k) review times · Search every ETK clearance

Top ETK applicants

Most recent ETK clearances

Recalls for ETK devices

openFDA lists no recalls for product code ETK.

Frequently asked questions

What is FDA product code ETK?

ETK is the FDA product code for tube, toynbee diagnostic. It is a Class I device, regulated under 21 CFR 874.1925 and reviewed by the Ear, Nose and Throat panel.

What device class is ETK?

Class I, regulation 21 CFR 874.1925. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code ETK?

Across 1 cleared submissions the average was 34 days from receipt to decision (median 34).

Which companies have the most ETK clearances?

Antares Technical Associates, Inc. (1).

Next steps

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