FDA product code FQA: Scale, Surgical Sponge

FQA is the FDA product code for scale, surgical sponge. It is a Class I device, regulated under 21 CFR 880.2740 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under FQA. The average 510(k) review took 34 days (median 34). FDA has posted 1 recall for FQA devices.

Classification

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

Top FQA applicants

Most recent FQA clearances

Recalls for FQA devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-04.

Frequently asked questions

What is FDA product code FQA?

FQA is the FDA product code for scale, surgical sponge. It is a Class I device, regulated under 21 CFR 880.2740 and reviewed by the General Hospital panel.

What device class is FQA?

Class I, regulation 21 CFR 880.2740. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 34 days from receipt to decision (median 34).

Which companies have the most FQA clearances?

Ritmed, Inc. (1).

Have FQA devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2018-12-04.

Next steps

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