SCV — Modular Electromechanical Surgical System Class II
FDA product code SCV covers "Modular Electromechanical Surgical System", a Class II medical device regulated under 21 CFR 878.4964. Submissions are reviewed by the General, Plastic Surgery panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SCV
- Device Class
- Class II
- Regulation Number
- 878.4964
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260804 | Momentis Surgical | Anovo Surgical System (6Ne) | Jul 22, 2026 |
| K252111 | Cmr Surgical Limited | Versius Surgical System (Versius Plus) | Dec 16, 2025 |
| K250725 | Covidien | Hugo RAS System | Dec 3, 2025 |
| DEN230078 | Cmr Surgical Limited | Versius Surgical System | Oct 11, 2024 |