# GCS: Endoscope, Battery-Powered And Accessories

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 9
- 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)
- 1992: 1
- 1993: 6
- 1994: 1
- 1995: 1

## Most-cited predicates
- K931340: Grasp Forceps/Scissors/Needle Holder/Dissector (1993), cited by 3

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