510(k) DEN230078
DEN230078 is an FDA 510(k) premarket notification submitted by Cmr Surgical Limited for the device "Versius Surgical System". The FDA issued a decision of De Novo Granted on October 11, 2024. The device falls under product code SCV (Modular Electromechanical Surgical System), a Class II device regulated under 21 CFR 878.4964. Cmr Surgical Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 11, 2024
- Date Received
- November 21, 2023
- Clearance Type
- Direct
- 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.