FDA product code · Gastroenterology and urology
Forceps, Biopsy, Electric
46 FDA decisions since 1989. 510(k) reviews decided 2021–2025 took a median of 220 days (half between 189 and 242). No recall names this code. The most-cited predicate is K062517, named by 6 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 KGE 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 · KGE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGE
184in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGE
No recall names KGE since 2007.
Adverse event reports per year · KGE
10in 2025
MAUDE reports naming product code KGE, 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 | 4 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 2 | — | 0 | 75 |
| 2010 | 1 | — | 0 | 29 |
| 2011 | 0 | — | 0 | 51 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 102 | 0 | 9 |
| 2017 | 2 | — | 0 | 26 |
| 2018 | 3 | 184 | 0 | 26 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 2 | — | 0 | 24 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
Planning a device in KGE? 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 876.4300.