FDA product code FCQ: Light Source, Incandescent, Diagnostic

FCQ is the FDA product code for light source, incandescent, diagnostic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FCQ. The average 510(k) review took 61 days (median 61).

Classification

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

Top FCQ applicants

Most recent FCQ clearances

Recalls for FCQ devices

openFDA lists no recalls for product code FCQ.

Frequently asked questions

What is FDA product code FCQ?

FCQ is the FDA product code for light source, incandescent, diagnostic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.

What device class is FCQ?

Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 61 days from receipt to decision (median 61).

Which companies have the most FCQ clearances?

Mitsubishi Cable America, Inc. (1).

Next steps

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