# HES: Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

- Device class: 2; regulation: 21 CFR 884.1300; FDA's rule: 510(k) required
- FDA decisions: 13
- 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)
- 1984: 1
- 1985: 1
- 1986: 1
- 1987: 1
- 1988: 1
- 1989: 2
- 1990: 4
- 2000: 1
- 2014: 1

## Most-cited predicates
- K891290: Sholkoff Balloon Hysterosalpingography Catheter (1989), cited by 1
- K890869: Bard Hysterosalpingography Catheters (1989), cited by 1

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