# ODF: Mini Endoscope, Gastroenterology-Urology

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1988: 1
- 1991: 2
- 1993: 1
- 1994: 1
- 1995: 1
- 1997: 1
- 2005: 2
- 2009: 2
- 2010: 1

## Most-cited predicates
- K050403: Spyglass Direct Visulation Probe (2005), cited by 4
- K052194: Spyglass Direct Visualization Probe and Ocular (2005), cited by 3
- K943593: Saratoga Modular Miniature Endoscope System (1995), cited by 1
- K091962: Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source, Model LS-200 (2009), cited by 1
- K963354: 5 Star Medical Endoscope (1997), cited by 1
- K090170: Spyscope Access and Delivery Catheter (2009), cited by 1
- K910732: Candela Mini-UB Endoscope (1991), cited by 1
- K912089: Modified Series 2100 Endoscopes (1991), cited by 1

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