FDA product code · Gastroenterology and urology

System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

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

EYZClass I21 CFR 876.5250510(k) exempt14 decisions since 19770 recalls

FDA lists EYZ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 14 FDA decisions since 1977. 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 EYZ 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 · EYZ

FDA has decided no EYZ device since 2007.

Median 510(k) review, days · EYZ

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

Recalls per year · EYZ

No recall names EYZ since 2007.

Adverse event reports per year · EYZ

1in 2021

2007high 1 (2007) · low 0 (2010)2025

MAUDE reports naming product code EYZ, 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	—	1
2008	—	1
2009	—	1
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	1
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	1
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in EYZ? 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

Related product codes

Other codes under 21 CFR 876.5250.

EXJ Device, Incontinence, Urosheath Type, Sterile FFH Collector, Urine, Pediatric, For Indwelling…KNX Collector, Urine, (And Accessories) For…EYT Sheath, Corrugated Rubber, For Nonindwelling…FAQ Bag, Urine Collection, Leg, For External Use…FOC Bag, Urine Collection, Newborn NNW Bag, Urine Collection, Leg, For External Use…NNY Sheath, Corrugated Rubber, For Non-Indwelling…EXI Device, Paste-On For Incontinence, Sterile NOA Device, Paste-On For Incontinence, Non-Sterile NNX Device, Incontinence, Urosheath Type…NNZ System, Urine Drainage, Closed, For…

System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

What has FDA decided in EYZ lately?

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