FDA product code · Ear, nose and throat

Tack, Sacculotomy (Cody Tack)

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

ESXClass II21 CFR 874.3760510(k) required1 decision since 19830 recalls

1 FDA decision since 1983. 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 ESX 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 · ESX

FDA has decided no ESX device since 2007.

Median 510(k) review, days · ESX

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

Recalls per year · ESX

No recall names ESX since 2007.

Adverse event reports per year · ESX

No MAUDE report names ESX 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 — ESX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ESX? 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

Tack, Sacculotomy (Cody Tack)

What has FDA decided in ESX lately?