# KOH: Instrument, Manual, General Obstetric-Gynecologic

- Device class: 1; regulation: 21 CFR 884.4520; FDA's rule: 510(k) exempt
- FDA decisions: 15
- Recalls: 1 (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)
- 1978: 2
- 1979: 1
- 1980: 1
- 1981: 1
- 1983: 1
- 1984: 1
- 1987: 1
- 1989: 4
- 1994: 2
- 2000: 1

## Most-cited predicates
- K891351: Newport Lateral Vaginal Retractor (1989), cited by 1

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