FDA product code · General and plastic surgery
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
32 FDA decisions since 1987. 510(k) reviews decided 2021–2025 took a median of 477 days (half between 477 and 477). 2 recalls name this code, 0 of them Class I. The most-cited predicate is K931271, named by 19 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 GAQ 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 · GAQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GAQ
Too few GAQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GAQ
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAQ
83in 2025
MAUDE reports naming product code GAQ, 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 | 7 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 2 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 17 |
| 2016 | 0 | — | 0 | 23 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 1 | — | 0 | 52 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 70 |
| 2023 | 0 | — | 0 | 100 |
| 2024 | 0 | — | 0 | 176 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 0 | — | 2 | — |
Planning a device in GAQ? 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 878.4495.