FDA product code · Gastroenterology and urology

Replacer, Urethral

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

FAAClass IIIPMA 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, gastroenterology and urology panel

Twenty years of FAA 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 · FAA

FDA has decided no FAA device since 2007.

Median 510(k) review, days · FAA

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

Recalls per year · FAA

No recall names FAA since 2007.

Adverse event reports per year · FAA

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

Planning a device in FAA? 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

Replacer, Urethral

What has FDA decided in FAA lately?