FDA product code FEZ: Catheter And Tube, Suprapubic

FEZ is the FDA product code for catheter and tube, suprapubic. It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FEZ. The average 510(k) review took 28 days (median 28). FDA has posted 2 recalls for FEZ devices, 1 initiated in the last five years.

Classification

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

Top FEZ applicants

Most recent FEZ clearances

Recalls for FEZ devices

2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.

Frequently asked questions

What is FDA product code FEZ?

FEZ is the FDA product code for catheter and tube, suprapubic. It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel.

What device class is FEZ?

Class II, regulation 21 CFR 876.5090. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 28 days from receipt to decision (median 28).

Which companies have the most FEZ clearances?

Mentor Corp. (1).

Have FEZ devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2022-05-25.

Next steps

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