SCV
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Modular Electromechanical Surgical System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4964
- Medical specialty
- General, Plastic Surgery
- FDA 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.
- Adverse events (MAUDE)
- 2025: 84 · 2026: 1,468
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Anovo Surgical System (6Ne) (K260804) | Momentis Surgical , Ltd. | 2026-07-22 |
| Versius Surgical System (Versius Plus) (K252111) | Cmr Surgical Limited | 2025-12-16 |
| Hugo™ RAS System (K250725) | Covidien, LLC | 2025-12-03 |
| Versius Surgical System (DEN230078) | Cmr Surgical Limited | 2024-10-11 |
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Every clearance here is in the API, with alerts when new ones post.