# FDG: Retractor, Fiberoptic

- Device class: 1; regulation: 21 CFR 876.4530; FDA's rule: 510(k) exempt
- FDA decisions: 2
- 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)
- 1994: 1
- 1997: 1

## Most-cited predicates
- K964561: Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR E-4020, Endolumina II Detachable Tips, 56FR, TA (1997), cited by 1

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