FDA product code · General and plastic surgery
Gauze/Sponge, Internal, X-Ray Detectable
FDA lists GDY 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. 111 FDA decisions since 1977. 18 recalls name this code, 1 of them Class I. The most-cited predicate is K920355, named by 1 later device.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of GDY 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 · GDY
FDA has decided no GDY device since 2007.
Median 510(k) review, days · GDY
Too few GDY 510(k)s in any year since 2007 to give a median.
Recalls per year · GDY
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GDY
112in 2025
MAUDE reports naming product code GDY, 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 | 15 |
| 2008 | 0 | — | 1 | 25 |
| 2009 | 0 | — | 0 | 96 |
| 2010 | 0 | — | 7 | 44 |
| 2011 | 0 | — | 0 | 38 |
| 2012 | 0 | — | 2 | 80 |
| 2013 | 0 | — | 0 | 40 |
| 2014 | 0 | — | 0 | 65 |
| 2015 | 0 | — | 2 | 122 |
| 2016 | 0 | — | 0 | 291 |
| 2017 | 0 | — | 1 | 252 |
| 2018 | 0 | — | 1 | 250 |
| 2019 | 0 | — | 1 | 177 |
| 2020 | 0 | — | 0 | 116 |
| 2021 | 0 | — | 0 | 134 |
| 2022 | 0 | — | 1 | 226 |
| 2023 | 0 | — | 0 | 98 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 112 |
| 2026 | 0 | — | 1 (1) | — |
Planning a device in GDY? 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