FDA product code · General and plastic surgery
Suture, Absorbable
1 FDA decision since 1980. 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 GAK 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 · GAK
FDA has decided no GAK device since 2007.
Median 510(k) review, days · GAK
Too few GAK 510(k)s in any year since 2007 to give a median.
Recalls per year · GAK
No recall names GAK since 2007.
Adverse event reports per year · GAK
24in 2025
MAUDE reports naming product code GAK, 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 | 2 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 22 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 23 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 0 | — | 0 | 22 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 0 | 33 |
| 2024 | 0 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 0 | — | 0 | — |
Planning a device in GAK? 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 878.4830.