FDA product code · Gastroenterology and urology
Snare, Flexible
63 FDA decisions since 1985. 510(k) reviews decided 2021–2025 took a median of 247 days (half between 137 and 253). 5 recalls name this code, 0 of them Class I. The most-cited predicate is K172729, named by 4 later devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of FDI 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 · FDI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FDI
247in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDI
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDI
274in 2025
MAUDE reports naming product code FDI, 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 | 0 | — | 0 | 48 |
| 2008 | 2 | — | 0 | 201 |
| 2009 | 1 | — | 0 | 265 |
| 2010 | 0 | — | 1 | 174 |
| 2011 | 1 | — | 0 | 177 |
| 2012 | 1 | — | 0 | 162 |
| 2013 | 3 | 87 | 0 | 191 |
| 2014 | 5 | 47 | 0 | 345 |
| 2015 | 3 | 62 | 1 | 195 |
| 2016 | 1 | — | 0 | 223 |
| 2017 | 1 | — | 0 | 154 |
| 2018 | 4 | 214 | 0 | 181 |
| 2019 | 3 | 100 | 0 | 135 |
| 2020 | 2 | — | 0 | 487 |
| 2021 | 1 | — | 0 | 211 |
| 2022 | 4 | 247 | 0 | 246 |
| 2023 | 1 | — | 0 | 209 |
| 2024 | 0 | — | 0 | 279 |
| 2025 | 0 | — | 2 | 274 |
| 2026 | 1 | — | 0 | — |
Planning a device in FDI? 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) ReportRelated product codes
Other codes under 21 CFR 876.4300.