# FCS: Light, Catheter, Fiberoptic, Glass, Ureteral

- Device class: 2; regulation: 21 CFR 876.4020; FDA's rule: 510(k) exempt
- FDA decisions: 10
- 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)
- 1988: 2
- 1993: 1
- 1994: 2
- 1995: 2
- 1998: 1
- 2006: 1
- 2015: 1

## Most-cited predicates
- K945088: Gabriel Ureteral Illuminator System II (1995), cited by 2
- K151243: STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] (2015), cited by 2
- K061548: Stryker Ureteral Illumination System IV (2006), cited by 1
- K982542: Stryker Ureteral Illuminator System Iii (1998), cited by 1

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