# GBS: Catheter, Ventricular, General & Plastic Surgery

- Device class: 1; regulation: 21 CFR 878.4200; FDA's rule: 510(k) exempt
- FDA decisions: 27
- Recalls: 20 (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)
- 1981: 2
- 1982: 3
- 1983: 1
- 1984: 1
- 1985: 4
- 1986: 5
- 1987: 5
- 1988: 3
- 1989: 1
- 1991: 1

## Most-cited predicates
- K912645: Atriums PDR Thoracic Catheter (1991), cited by 1

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