# FHX: Jelly, Lubricating, For Transurethral Surgical Instrument

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 1977: 1
- 1978: 1
- 1991: 1
- 1994: 1
- 1995: 1
- 2008: 1

## Most-cited predicates
- K081990: Lubricano Sterile Gel (2008), cited by 1
- K780386: K-Y Lubricating Jelly (1978), cited by 1

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