FDA product code EYX: Drape, Pure Latex Sheet, With Self-Retaining Finger Cot

EYX is the FDA product code for drape, pure latex sheet, with self-retaining finger cot. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under EYX. The average 510(k) review took 55 days (median 55).

Classification

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

Top EYX applicants

Most recent EYX clearances

Recalls for EYX devices

openFDA lists no recalls for product code EYX.

Frequently asked questions

What is FDA product code EYX?

EYX is the FDA product code for drape, pure latex sheet, with self-retaining finger cot. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel.

What device class is EYX?

Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 55 days from receipt to decision (median 55).

Which companies have the most EYX clearances?

V. Mueller O.V. Baxter Healthcare Corp. (1).

Next steps

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