# FHN: Ligator, Hemorrhoidal

- Device class: 2; regulation: 21 CFR 876.4400; FDA's rule: 510(k) exempt
- FDA decisions: 22
- 510(k) review time 2021–2025: median 250 days (middle half 250–250)
- Recalls: 5 (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)
- 1998: 2
- 2000: 3
- 2002: 2
- 2007: 1
- 2009: 1
- 2010: 1
- 2013: 1
- 2015: 1
- 2018: 1
- 2022: 1

## Most-cited predicates
- K963166: O'regan Ligator (1997), cited by 2
- K000297: Erchinger Hemorrhoidal Ligators: Suction Ligators, Mod. Erchinger, Rudd, Mcgivney Mod. Erchinger (2000), cited by 2
- K070881: Lem Hemorrhoidal Ligator, Models a.5650, a.5660 (2007), cited by 2
- K091519: Haemoband Multi-Ligator (2009), cited by 2
- K020526: Modification to Wilson-Cook Multiple Band Ligator (2002), cited by 1
- K131282: Nexus Hemorrhoid Ligator (2013), cited by 1
- K952262: Speedband (1996), cited by 1
- K020824: Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238 (2002), cited by 1
- K974018: Wilson-Cook 10 Shot Multi-Band Ligator (1998), cited by 1

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