FDA product code FBX: Sound, Urethral, Metal Or Plastic

FBX is the FDA product code for sound, urethral, metal or plastic. It is a Class I device, regulated under 21 CFR 876.5520 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FBX. The average 510(k) review took 21 days (median 21). FDA has posted 1 recall for FBX devices, 1 initiated in the last five years.

Classification

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

Top FBX applicants

Most recent FBX clearances

Recalls for FBX devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.

Frequently asked questions

What is FDA product code FBX?

FBX is the FDA product code for sound, urethral, metal or plastic. It is a Class I device, regulated under 21 CFR 876.5520 and reviewed by the Gastroenterology and Urology panel.

What device class is FBX?

Class I, regulation 21 CFR 876.5520. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).

Which companies have the most FBX clearances?

Candela Laser Corp. (1).

Have FBX devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-03.

Next steps

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