FDA product code · General and plastic surgery
Applier, Staple, Surgical,
FDA lists GEF as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 4 FDA decisions since 1983. 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 GEF 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 · GEF
FDA has decided no GEF device since 2007.
Median 510(k) review, days · GEF
Too few GEF 510(k)s in any year since 2007 to give a median.
Recalls per year · GEF
No recall names GEF since 2007.
Adverse event reports per year · GEF
51in 2025
MAUDE reports naming product code GEF, 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 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 19 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 40 |
| 2015 | 0 | — | 0 | 119 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 74 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
Planning a device in GEF? 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 878.4800.