FDA product code · Orthopedic

Instrument, Cast Application/Removal, Manual

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

LGGClass I21 CFR 888.5980510(k) exempt3 decisions since 19840 recalls

FDA lists LGG as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 888.9 applies, such as a new intended use or a different fundamental technology. 3 FDA decisions since 1984. 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, orthopedic panel

Twenty years of LGG 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 · LGG

FDA has decided no LGG device since 2007.

Median 510(k) review, days · LGG

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

Recalls per year · LGG

No recall names LGG since 2007.

Adverse event reports per year · LGG

3in 2010

2007high 3 (2010) · low 0 (2007)2025

MAUDE reports naming product code LGG, 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	—	0
2008	—	0
2009	—	0
2010	—	3
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 — LGG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LGG? 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

Instrument, Cast Application/Removal, Manual

What has FDA decided in LGG lately?