FDA product code FBS: Sound, Metal, Interconnected

FBS is the FDA product code for sound, metal, interconnected. It is a Class I device, regulated under 21 CFR 876.4590 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FBS. The average 510(k) review took 89 days (median 89).

Classification

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

Top FBS applicants

Most recent FBS clearances

Recalls for FBS devices

openFDA lists no recalls for product code FBS.

Frequently asked questions

What is FDA product code FBS?

FBS is the FDA product code for sound, metal, interconnected. It is a Class I device, regulated under 21 CFR 876.4590 and reviewed by the Gastroenterology and Urology panel.

What device class is FBS?

Class I, regulation 21 CFR 876.4590. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 89 days from receipt to decision (median 89).

Which companies have the most FBS clearances?

Venture Management Corp. (1).

Next steps

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