# FXN: Tape, Camera, Surgical

- Device class: 1; regulation: 21 CFR 878.4160; FDA's rule: 510(k) exempt
- FDA decisions: 4
- 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)
- 1996: 1
- 2007: 1
- 2013: 2

## Most-cited predicates
- K131596: Wound Measuring & Monitoring Device (2013), cited by 4
- K070426: Silhouette, Model 1000.01 (2007), cited by 1

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