# FSO: Microscope, Surgical, General & Plastic Surgery

- Device class: 1; regulation: 21 CFR 878.4700; FDA's rule: 510(k) exempt
- FDA decisions: 15
- 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)
- 1979: 1
- 1980: 2
- 1982: 3
- 1987: 1
- 1990: 1
- 1991: 1
- 1993: 4
- 1994: 2

## Most-cited predicates
- K920689: Deemed MSS -- Microscope Support System (1993), cited by 1

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