510(k) K250725
K250725 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Hugo RAS System". The FDA issued a decision of Substantially Equivalent on December 3, 2025. The device falls under product code SCV (Modular Electromechanical Surgical System), a Class II device regulated under 21 CFR 878.4964. Covidien, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2025
- Date Received
- March 10, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Modular Electromechanical Surgical System
- Device Class
- Class II
- Regulation Number
- 878.4964
- Review Panel
- SU
- Submission Type
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.