FDA product code · Gastroenterology and urology

External Urethral Occluder, Urinary Incontinence-Control, Female

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

MNGClass I21 CFR 876.5160510(k) exempt7 decisions since 19960 recalls

FDA lists MNG 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. 7 FDA decisions since 1996. No recall names this code. The most-cited predicate is K971359, named by 1 later device.

Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.

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 MNG 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 · MNG

FDA has decided no MNG device since 2007.

Median 510(k) review, days · MNG

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

Recalls per year · MNG

No recall names MNG since 2007.

Adverse event reports per year · MNG

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

Planning a device in MNG? 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 876.5160.

FHA Clamp, Penile

External Urethral Occluder, Urinary Incontinence-Control, Female

Which predicates do MNG devices cite most?

Which MNG devices have the deepest lineage?

What has FDA decided in MNG lately?

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