# GDB: Endoscope, Fiber Optic

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 7
- Recalls: 0 (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: 1
- 1984: 1
- 1986: 1
- 1988: 1
- 1994: 1
- 1996: 1
- 2003: 1

## Most-cited predicates
- K882061: Olympus GF-UM3/EU-M3 (1988), cited by 3
- K935818: Endoscope (1994), cited by 1
- K032283: Designs for Vision Fiberoptic Light (2003), cited by 1

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