FDA product code · Gastroenterology and urology

Spermatocele, Alloplastic

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

LQSClass U510(k) required1 decision since 19860 recalls

1 FDA decision since 1986. 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 LQS 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 · LQS

FDA has decided no LQS device since 2007.

Median 510(k) review, days · LQS

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

Recalls per year · LQS

No recall names LQS since 2007.

Adverse event reports per year · LQS

2in 2007

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code LQS, 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	—	2
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 — LQS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LQS? 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

Spermatocele, Alloplastic

What has FDA decided in LQS lately?