# FBQ: Trocar, Gastro-Urology

- Device class: 2; 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)
- 1984: 1
- 1990: 1
- 1991: 1
- 1993: 1
- 1994: 3
- 1998: 1
- 2001: 1

## Most-cited predicates
- K012198: Gibbons Sterile Trocar Kits (2001), cited by 1

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