FDA product code FXG: Specula Accessories

FXG is the FDA product code for specula accessories. 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 FXG. The average 510(k) review took 29 days (median 29). FDA has posted 1 recall for FXG devices, 1 initiated in the last five years.

Classification

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

Top FXG applicants

Most recent FXG clearances

Recalls for FXG devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-02-28.

Frequently asked questions

What is FDA product code FXG?

FXG is the FDA product code for specula accessories. 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 FXG?

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

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

Across 1 cleared submissions the average was 29 days from receipt to decision (median 29).

Which companies have the most FXG clearances?

Semantodontics, Inc. (1).

Have FXG devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2022-02-28.

Next steps

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

All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times