FDA product code FAL: Panendoscope (Urethroscope)

FAL is the FDA product code for panendoscope (urethroscope). 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 FAL. The average 510(k) review took 146 days (median 146).

Classification

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

Top FAL applicants

Most recent FAL clearances

Recalls for FAL devices

openFDA lists no recalls for product code FAL.

Frequently asked questions

What is FDA product code FAL?

FAL is the FDA product code for panendoscope (urethroscope). It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.

What device class is FAL?

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

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

Across 1 cleared submissions the average was 146 days from receipt to decision (median 146).

Which companies have the most FAL clearances?

C.R. Bard, Inc. (1).

Next steps

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