K250725 is an FDA 510(k) clearance for the Hugo™ RAS System. This device is classified as a Modular Electromechanical Surgical System (Class II - Special Controls, product code SCV).
Submitted by Covidien, LLC (North Haven, US). The FDA issued a Cleared decision on December 3, 2025, 268 days after receiving the submission on March 10, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4964. A Modular Electromechanical Surgical System Is A Software-controlled Electromechanical System With A Plurality Of Individual, Fully Positionable Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures..
| 510(k) Number | K250725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2025 |
| Decision Date | December 03, 2025 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | SCV — Modular Electromechanical Surgical System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4964 |
| Definition | A Modular Electromechanical Surgical System Is A Software-controlled Electromechanical System With A Plurality Of Individual, Fully Positionable Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures. |