# DEN220047: Galen ES Cooperative Surgical Assistant Platform, Galen ES

- Pathway: De Novo (Direct)
- Applicant: Galen Robotics
- Decided: Jul 19, 2023 after 362 days
- Product code: QXG (Cooperative Powered Surgical Assist Device For Ent Surgery)
- Device class: 2
- Regulation: 21 CFR 874.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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.

Source page: https://510kreport.com/device/DEN220047
Methodology: https://510kreport.com/methodology