# FFS: Image, Illumination, Fiberoptic, For Endoscope

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 26
- 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)
- 1994: 4
- 1995: 1
- 1996: 1
- 1997: 1
- 1998: 3
- 1999: 1
- 2000: 2
- 2002: 1
- 2006: 1
- 2007: 3

## Most-cited predicates
- K962595: Karl Storz Xenon 300 Light Source for Non-Flash Applications (1996), cited by 5
- K001698: Micro Link Endoscopic Fiber Cable, Model B1-90159 (2000), cited by 3
- K983714: Solartec Source 270, Model # 90123 (1998), cited by 2
- K991323: Smith & Nephew Subcutaneous Illuminator (1999), cited by 1
- K061025: Accutech Endolite Probe (2006), cited by 1
- K994084: Smith & Nephew Xenon Light Sources and Accessories (2000), cited by 1
- K982462: Fiber Optic Endoillumination Probe (1998), cited by 1
- K023633: Sovis Optique's Endoscopic Cable (2002), cited by 1

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