510(k) Report

FDA product code · Gastroenterology and urology

Stent, Urethral, External Sphincter, Permanent

MXQClass IIIPMA required0 decisions since 19990 recalls

0 FDA decisions since 1999. 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 MXQ 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 · MXQ

FDA has decided no MXQ device since 2007.

Median 510(k) review, days · MXQ

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

Recalls per year · MXQ

No recall names MXQ since 2007.

Adverse event reports per year · MXQ

No MAUDE report names MXQ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MXQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MXQ? 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