FDA product code · Neurology

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

GWXClass I21 CFR 882.1525510(k) exempt4 decisions since 19760 recalls

FDA lists GWX as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 882.9 applies, such as a new intended use or a different fundamental technology. 4 FDA decisions since 1976. 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 GWX 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 · GWX

FDA has decided no GWX device since 2007.

Median 510(k) review, days · GWX

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

Recalls per year · GWX

No recall names GWX since 2007.

Adverse event reports per year · GWX

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

Planning a device in GWX? 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

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What has FDA decided in GWX lately?