# GAE: Snare, Surgical

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 4
- Recalls: 2 (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)
- 1988: 1
- 1991: 1
- 1993: 1
- 1995: 1

## Most-cited predicates
- K881224: Acufex Suture Retriever, Sterile Disposable (1988), cited by 1
- K926036: Acufex Suture Retriever (1993), cited by 1

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