FDA product code · Gastroenterology and urology
Anoscope And Accessories
27 FDA decisions since 1977. 510(k) reviews decided 2021–2025 took a median of 262 days (half between 189 and 320). 1 recall names this code; it is not Class I. The most-cited predicate is K070913, named by 5 later devices.
To examine and perform procedures within the anus and rectum.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of FER 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 · FER
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FER
Too few FER 510(k)s in any year since 2007 to give a median.
Recalls per year · FER
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FER
3in 2025
MAUDE reports naming product code FER, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
Planning a device in FER? 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 876.1500.