# FGS: Carrier, Sponge, Endoscopic

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) exempt
- FDA decisions: 4
- Recalls: 1 (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)
- 1982: 1
- 1993: 3

## Most-cited predicates

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