# EPT: Microscope, Surgical

- Device class: 1; regulation: 21 CFR 878.4700; FDA's rule: 510(k) exempt
- FDA decisions: 18
- Recalls: 6 (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)
- 1976: 1
- 1981: 3
- 1982: 5
- 1983: 1
- 1985: 1
- 1986: 1
- 1988: 2
- 1990: 1
- 1993: 2
- 1994: 1

## Most-cited predicates
- K942233: MKM (Multiple Coordinate Manipulator) System (1994), cited by 2

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