# MND: Ligator, Esophageal

- Device class: 2; regulation: 21 CFR 876.4400; FDA's rule: 510(k) exempt
- FDA decisions: 15
- Recalls: 4 (1 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
- 1997: 2
- 1999: 2
- 2001: 2
- 2002: 1
- 2003: 2
- 2005: 1
- 2008: 1
- 2009: 1
- 2013: 1

## Most-cited predicates
- K013066: HX-5/6-1 Endoscopic Clipping Device (2001), cited by 2
- K964661: HX-20/21-1 Endoscopic Ligator (1997), cited by 2
- K031236: Auto-Band Ligator (2003), cited by 2
- K051950: Inscope Multi-Clip Applier, Models IN22321, IN23321 (2005), cited by 2
- K083556: Modification to Auto-Band Ligator (2009), cited by 1
- K940661: Stiegmann-Goff Endoscopic Ligator (1994), cited by 1
- K944220: Wilson Cook Multiple Band Ligator (1995), cited by 1
- K081142: Auto-Band Ligator (2008), cited by 1

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