FDA product code · Gastroenterology and urology
Agent, Bulking, Injectable For Gastro-Urology Use
9 FDA decisions since 1993. 2 recalls name this code, 0 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 LNM 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 · LNM
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNM
Too few LNM 510(k)s in any year since 2007 to give a median.
Recalls per year · LNM
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LNM
59in 2025
MAUDE reports naming product code LNM, 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 | 19 | — | 0 | 45 |
| 2008 | 26 | — | 0 | 25 |
| 2009 | 18 | — | 0 | 25 |
| 2010 | 9 | — | 0 | 38 |
| 2011 | 10 | — | 0 | 55 |
| 2012 | 12 | — | 0 | 60 |
| 2013 | 12 | — | 0 | 62 |
| 2014 | 16 | — | 0 | 52 |
| 2015 | 7 | — | 0 | 59 |
| 2016 | 3 | — | 0 | 72 |
| 2017 | 7 | — | 0 | 86 |
| 2018 | 7 | — | 0 | 36 |
| 2019 | 10 | — | 0 | 8 |
| 2020 | 23 | — | 1 | 7 |
| 2021 | 5 | — | 0 | 11 |
| 2022 | 13 | — | 0 | 18 |
| 2023 | 14 | — | 0 | 16 |
| 2024 | 8 | — | 0 | 65 |
| 2025 | 7 | — | 0 | 59 |
| 2026 | 7 | — | 0 | — |
Planning a device in LNM? 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