FDA product code · Neurology

Echoencephalograph

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

GXWClass II21 CFR 882.1240510(k) required7 decisions since 19770 recalls

7 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, neurology panel

Twenty years of GXW 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 · GXW

FDA has decided no GXW device since 2007.

Median 510(k) review, days · GXW

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

Recalls per year · GXW

No recall names GXW since 2007.

Adverse event reports per year · GXW

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

Planning a device in GXW? 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

Echoencephalograph

What has FDA decided in GXW lately?