# GEC: Brush, Scrub, Operating-Room

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 37
- 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)
- 1982: 5
- 1983: 4
- 1984: 2
- 1985: 1
- 1987: 3
- 1988: 3
- 1989: 1
- 1990: 1
- 1996: 1
- 1997: 1

## Most-cited predicates
- K791736: Merocel Instrument Wipe (1979), cited by 2

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