FDA product code FEJ: Attachment, Binocular, For Endoscope

FEJ is the FDA product code for attachment, binocular, for endoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FEJ. The average 510(k) review took 395 days (median 395).

Classification

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Recalls for FEJ devices

openFDA lists no recalls for product code FEJ.

Frequently asked questions

What is FDA product code FEJ?

FEJ is the FDA product code for attachment, binocular, for endoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.

What device class is FEJ?

Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 395 days from receipt to decision (median 395).

Which companies have the most FEJ clearances?

Manico (1).

Next steps

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