# SDD: Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

- Device class: 2; regulation: 21 CFR 878.4965; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 134 days (middle half 118–150)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2024: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- K251197: Dexter L6 System (2025), cited by 2
- DEN230084: Dexter L6 System (2024), cited by 2

Source page: https://510kreport.com/product-code/SDD
Data by year (CSV): https://510kreport.com/product-code/SDD.csv