FDA product code FZM: Stool, Operating-Room

FZM is the FDA product code for stool, operating-room. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under FZM. The average 510(k) review took 22 days (median 22). FDA has posted 1 recall for FZM devices.

Classification

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

Top FZM applicants

Most recent FZM clearances

Recalls for FZM devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-05-12.

Frequently asked questions

What is FDA product code FZM?

FZM is the FDA product code for stool, operating-room. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel.

What device class is FZM?

Class I, regulation 21 CFR 878.4950. Typical premarket route: 510(k) exempt.

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

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

Which companies have the most FZM clearances?

Valley Forge Scientific Corp. (1).

Have FZM devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2021-05-12.

Next steps

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