FDA product code ESI: Polymer, Natural-Absorbable Gelatin Material

ESI is the FDA product code for polymer, natural-absorbable gelatin material. It is a Class III device, reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under ESI, from 2 different applicants. The average 510(k) review took 142 days (median 142).

Classification

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

Top ESI applicants

Most recent ESI clearances

Recalls for ESI devices

openFDA lists no recalls for product code ESI.

Frequently asked questions

What is FDA product code ESI?

ESI is the FDA product code for polymer, natural-absorbable gelatin material. It is a Class III device, reviewed by the Ear, Nose and Throat panel.

What device class is ESI?

Class III. Typical premarket route: PMA.

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

Across 2 cleared submissions the average was 142 days from receipt to decision (median 142).

Which companies have the most ESI clearances?

Patrick C. Jacobssen (1); Leisegang Medical, Inc. (1).

Next steps

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