FDA product code · Obstetrics and gynecology
Barrier, Absorbable, Adhesion
6 FDA decisions since 1989. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MCN 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 · MCN
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCN
Too few MCN 510(k)s in any year since 2007 to give a median.
Recalls per year · MCN
No recall names MCN since 2007.
Adverse event reports per year · MCN
38in 2025
MAUDE reports naming product code MCN, 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 | 32 |
| 2008 | 3 | — | 0 | 61 |
| 2009 | 2 | — | 0 | 73 |
| 2010 | 5 | — | 0 | 42 |
| 2011 | 8 | — | 0 | 68 |
| 2012 | 4 | — | 0 | 48 |
| 2013 | 3 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 53 |
| 2015 | 2 | — | 0 | 68 |
| 2016 | 7 | — | 0 | 71 |
| 2017 | 5 | — | 0 | 58 |
| 2018 | 1 | — | 0 | 65 |
| 2019 | 7 | — | 0 | 55 |
| 2020 | 7 | — | 0 | 44 |
| 2021 | 8 | — | 0 | 42 |
| 2022 | 7 | — | 0 | 53 |
| 2023 | 4 | — | 0 | 45 |
| 2024 | 9 | — | 0 | 38 |
| 2025 | 6 | — | 0 | 38 |
| 2026 | 6 | — | 0 | — |
Planning a device in MCN? 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