FDA product code · Neurology

Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease

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

LLEClass IIIPathway set case by case2 decisions since 19830 recalls

2 FDA decisions 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, neurology panel

Twenty years of LLE 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 · LLE

FDA has decided no LLE device since 2007.

Median 510(k) review, days · LLE

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

Recalls per year · LLE

No recall names LLE since 2007.

Adverse event reports per year · LLE

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

Planning a device in LLE? 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

Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease

What has FDA decided in LLE lately?