FDA product code FXF: Speculum, Illuminated

FXF is the FDA product code for speculum, illuminated. It is a Class I device, regulated under 21 CFR 878.1800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under FXF. The average 510(k) review took 22 days (median 22).

Classification

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

Top FXF applicants

Most recent FXF clearances

Recalls for FXF devices

openFDA lists no recalls for product code FXF.

Frequently asked questions

What is FDA product code FXF?

FXF is the FDA product code for speculum, illuminated. It is a Class I device, regulated under 21 CFR 878.1800 and reviewed by the General and Plastic Surgery panel.

What device class is FXF?

Class I, regulation 21 CFR 878.1800. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 22 days from receipt to decision (median 22).

Which companies have the most FXF clearances?

Designs For Vision, Inc. (1).

Next steps

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