FDA product code EPY: Speculum, Ent

EPY is the FDA product code for speculum, ent. It is a Class I device, regulated under 21 CFR 878.1800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 12 510(k) submissions under EPY, from 9 different applicants. The average 510(k) review took 63 days (median 26). FDA has posted 2 recalls for EPY devices, 2 initiated in the last five years.

Classification

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

Top EPY applicants

4 more applicants have EPY clearances. See the full list in Caduvo.

Most recent EPY clearances

Recalls for EPY devices

2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-12-03.

Frequently asked questions

What is FDA product code EPY?

EPY is the FDA product code for speculum, ent. It is a Class I device, regulated under 21 CFR 878.1800 and reviewed by the General and Plastic Surgery panel.

What device class is EPY?

Class I, regulation 21 CFR 878.1800. Typical premarket route: 510(k) exempt.

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

Across 12 cleared submissions the average was 63 days from receipt to decision (median 26).

Which companies have the most EPY clearances?

Edward Weck, Inc. (3); Treace Medical, Inc. (2); Pedia Pals, Inc. (1); Rudolf Riester GmbH & Co. KG (1); Downs Surgical , Ltd. (1).

Have EPY devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2024-12-03.

Next steps

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