# FHO: Pneumoperitoneum Needle

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 15
- 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)
- 1991: 3
- 1992: 1
- 1993: 1
- 1994: 2
- 1995: 1
- 1996: 1
- 1997: 1
- 2001: 1
- 2013: 1
- 2017: 1

## Most-cited predicates
- K970788: Pneumo-Matic Insufflation Needle (1997), cited by 1
- K172120: Veress Needle (2017), cited by 1

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