DEN220047 is an FDA 510(k) submission for the Galen ES Cooperative Surgical Assistant Platform, Galen ES. This device is classified as a Cooperative Powered Surgical Assist Device For Ent Surgery (Class II - Special Controls, product code QXG).
Submitted by Galen Robotics (Baltimore, US). The FDA issued a Not Cleared (DENG) decision on July 19, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4460. A Cooperative Powered Surgical Assist Device For Ear, Nose, And Throat (ent) Surgery Is A Device That Facilitates Ent Surgical Procedures, Including Instrument Placement. The Device Works In Conjunction With The Surgeon's Movements To Assist With Precise And Stable Positioning Of An Instrument While Maintaining The Surgeons Direct Physical Control Of The Instrument..
| 510(k) Number | DEN220047 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 22, 2022 |
| Decision Date | July 19, 2023 |
| Days to Decision | 362 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | QXG - Cooperative Powered Surgical Assist Device For Ent Surgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4460 |
| Definition | A Cooperative Powered Surgical Assist Device For Ear, Nose, And Throat (ent) Surgery Is A Device That Facilitates Ent Surgical Procedures, Including Instrument Placement. The Device Works In Conjunction With The Surgeon's Movements To Assist With Precise And Stable Positioning Of An Instrument While Maintaining The Surgeons Direct Physical Control Of The Instrument. |