FDA product code · Gastroenterology and urology
Electrode, Electrosurgical, Active, Urological
58 FDA decisions since 1990. 510(k) reviews decided 2021–2025 took a median of 139 days (half between 116 and 155). 7 recalls name this code, 0 of them Class I. The most-cited predicate is K955531, named by 7 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 FAS 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 · FAS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAS
150in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAS
395in 2025
MAUDE reports naming product code FAS, 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 | 6 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 3 | 150 | 0 | 25 |
| 2011 | 1 | — | 0 | 33 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 2 | 69 |
| 2017 | 2 | — | 0 | 121 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 61 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 2 | — | 4 | 102 |
| 2022 | 1 | — | 0 | 147 |
| 2023 | 0 | — | 1 | 329 |
| 2024 | 1 | — | 0 | 310 |
| 2025 | 2 | — | 0 | 395 |
| 2026 | 0 | — | 0 | — |
Planning a device in FAS? 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.