# GBW: Catheter, Peritoneal

- Device class: 1; regulation: 21 CFR 878.4200; FDA's rule: 510(k) exempt
- FDA decisions: 17
- Recalls: 13 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1981: 3
- 1984: 1
- 1986: 1
- 1989: 2
- 1991: 1
- 1993: 1
- 1994: 1
- 1996: 3
- 1997: 1
- 1999: 2

## Most-cited predicates
- K942709: Mediastinal Silicone Drains (1996), cited by 3
- K992904: Mini-Port (1999), cited by 2

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