De Novo · Granted
GrantedGalen ES Cooperative Surgical Assistant Platform, Galen ES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galen Robotics · QXG Cooperative Powered Surgical Assist Device For Ent Surgery
Granted on Jul 19, 2023 as a new device type through De Novo after a 362-day review.
- Decided
- Jul 19, 2023
- Review
- 362 days
- Class
- Class II
- Product code
- QXG
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QXG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QXG devicesQXG Cooperative Powered Surgical Assist Device For Ent Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QXG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QXG
Too few QXG 510(k)s in any year since 2007 to give a median.
Recalls per year · QXG
No recall names QXG since 2007.
Adverse event reports per year · QXG
No MAUDE report names QXG since 2007.
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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Galen ES is intended to assist in the movement of the specified Integra Jako Micro Laryngeal Alligator Forceps to a surgeon-selected position within a surgical field and remain in place until moved elsewhere by the operator. The Galen ES is indicated to be used in rigid microlaryngeal procedures where the specified Jako Micro Laryngeal Alligator Forceps would be utilized by an experienced trained otolaryngologist performing microlaryngeal surgery in an operating room environment in patients at least 18 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220047 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220047: Galen ES Cooperative Surgical Assistant Platform, Galen ES.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220047
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026