FDA product code · Gastroenterology and urology

Prosthesis, Vas Deferens

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

EZZClass IIIPMA required1 decision since 19850 recalls

1 FDA decision since 1985. 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, gastroenterology and urology panel

Twenty years of EZZ 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 · EZZ

FDA has decided no EZZ device since 2007.

Median 510(k) review, days · EZZ

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

Recalls per year · EZZ

No recall names EZZ since 2007.

Adverse event reports per year · EZZ

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

Planning a device in EZZ? 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

Prosthesis, Vas Deferens

What has FDA decided in EZZ lately?