FDA product code · Ear, nose and throat

Polymer, Natural-Absorbable Gelatin Material

Name: FDA decisions, review times, recalls and adverse event reports for product code ESI
Creator: 510(k) Report

ESIClass IIIPMA required2 decisions since 19910 recalls

2 FDA decisions since 1991. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ear, nose and throat panel

Twenty years of ESI at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · ESI

FDA has decided no ESI device since 2007.

Median 510(k) review, days · ESI

Too few ESI 510(k)s in any year since 2007 to give a median.

Recalls per year · ESI

No recall names ESI since 2007.

Adverse event reports per year · ESI

No MAUDE report names ESI since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — ESI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ESI? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Polymer, Natural-Absorbable Gelatin Material

What has FDA decided in ESI lately?