# MOK: Vaginoscope And Accessories

- Device class: 2; regulation: 21 CFR 884.1630; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 165 days (middle half 165–165)
- 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)
- 1995: 1
- 2022: 1

## Most-cited predicates
- K950639: Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers, Adjustable Magnifiers (1995), cited by 1

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