FDA product code · Ear, nose and throat

Tube, Shunt, Endolymphatic

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

ESZClass II21 CFR 874.3820510(k) required4 decisions since 19840 recalls

4 FDA decisions since 1984. 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 ESZ 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 · ESZ

FDA has decided no ESZ device since 2007.

Median 510(k) review, days · ESZ

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

Recalls per year · ESZ

No recall names ESZ since 2007.

Adverse event reports per year · ESZ

1in 2020

2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code ESZ, not matched to any one device; reports are not rates.

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	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	1
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in ESZ? 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

Tube, Shunt, Endolymphatic

What has FDA decided in ESZ lately?