# EGM: Injector, Jet, Mechanical-Powered

- Device class: 2; regulation: 21 CFR 872.4475; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 269 days (middle half 269–269)
- 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)
- 1979: 1
- 1982: 1
- 1984: 1
- 1987: 3
- 1990: 1
- 1996: 1
- 1997: 1
- 2010: 1
- 2025: 1

## Most-cited predicates
- K964802: Cyberjet Local Anesthesia System (1997), cited by 1
- K083811: W&H Handpiece Anesto, Model: RA-5 (2010), cited by 1

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