# QNM: Mountable Electromechanical Surgical System For Transluminal Approaches

- Device class: 2; regulation: 21 CFR 878.4961; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 90 days (middle half 43–96)
- 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)
- 2021: 1
- 2023: 1
- 2024: 2
- 2025: 4

## Most-cited predicates
- DEN190022: Hominis Surgical System (2021), cited by 4
- K241907: Anovo Surgical System  (model 6N) (2024), cited by 1
- K243182: Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (2025), cited by 1
- K242157: Anovo Surgical System (Model 6Ne) (2024), cited by 1

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