# GEA: Cannula, Surgical, General & Plastic Surgery

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 36
- Recalls: 5 (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)
- 1986: 4
- 1987: 4
- 1988: 1
- 1989: 4
- 1990: 5
- 1991: 2
- 1992: 2
- 1995: 1
- 1999: 1
- 2001: 1

## Most-cited predicates
- K832520: Suction Tips (1983), cited by 5
- K920110: Endopath Disposable Thoracic Trocar Sleeve (1992), cited by 1
- K862936: Newman Cannulae System (NCS) (1986), cited by 1

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