# GBO: Catheter, Nephrostomy, General & Plastic Surgery

- Device class: 1; regulation: 21 CFR 878.4200; FDA's rule: 510(k) exempt
- FDA decisions: 11
- Recalls: 3 (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)
- 1978: 1
- 1979: 1
- 1982: 1
- 1986: 5
- 1991: 1
- 2002: 1
- 2004: 1

## Most-cited predicates
- K854909: Pediatric Percutaneous Nephrostomy Sets (1986), cited by 1

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