FDA product code · General and plastic surgery
Mesh, Surgical, Absorbable, Staple Line Reinforcement
9 FDA decisions since 2013. 510(k) reviews decided 2021–2025 took a median of 127 days (half between 111 and 129). No recall names this code. The most-cited predicate is K130997, named by 2 later devices.
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OXC 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 · OXC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OXC
Too few OXC 510(k)s in any year since 2007 to give a median.
Recalls per year · OXC
No recall names OXC since 2007.
Adverse event reports per year · OXC
45in 2025
MAUDE reports naming product code OXC, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 2 | — | 0 | 164 |
| 2023 | 1 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 38 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 1 | — | 0 | — |
Planning a device in OXC? 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 878.3300.