FDA product code · Neurology
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
8 FDA decisions since 1981. 42 recalls name this code, 1 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LGW 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 · LGW
65in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGW
Too few LGW 510(k)s in any year since 2007 to give a median.
Recalls per year · LGW
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LGW
31,054in 2025
MAUDE reports naming product code LGW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | — | 4 | 1,094 |
| 2008 | 53 | — | 4 | 3,018 |
| 2009 | 38 | — | 2 | 5,251 |
| 2010 | 56 | — | 2 | 9,265 |
| 2011 | 47 | — | 1 | 11,132 |
| 2012 | 68 | — | 1 | 17,915 |
| 2013 | 71 | — | 3 | 22,432 |
| 2014 | 68 | — | 0 | 11,250 |
| 2015 | 72 | — | 0 | 11,690 |
| 2016 | 92 | — | 2 | 15,643 |
| 2017 | 94 | — | 2 | 18,612 |
| 2018 | 64 | — | 0 | 23,626 |
| 2019 | 69 | — | 0 | 30,038 |
| 2020 | 52 | — | 1 | 28,106 |
| 2021 | 56 | — | 1 | 24,333 |
| 2022 | 60 | — | 5 | 23,269 |
| 2023 | 63 | — | 2 | 33,528 |
| 2024 | 94 | — | 2 | 35,074 |
| 2025 | 65 | — | 3 | 31,054 |
| 2026 | 56 | — | 2 (1) | — |
Planning a device in LGW? 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