# FBM: Cannula And Trocar, Suprapubic, Non-Disposable

- Device class: 1; regulation: 21 CFR 876.5090; FDA's rule: 510(k) exempt
- FDA decisions: 9
- 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)
- 1990: 6
- 1991: 1
- 1994: 1
- 1996: 1

## Most-cited predicates
- K960400: Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) (1996), cited by 4
- K911813: Entree Cannula (1991), cited by 1

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