# MGZ: Valvulotome

- Device class: 2; regulation: 21 CFR 870.4885; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 172 days (middle half 170–173)
- 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)
- 2001: 1
- 2004: 1
- 2008: 1
- 2011: 1
- 2013: 2
- 2014: 2
- 2019: 1
- 2022: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K132190: Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome (2013), cited by 3
- K930011: Uresil Valve Cutter with Interchangeable Heads (1993), cited by 2
- K221902: LimFlow Vector (2022), cited by 1
- K980723: 2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT) (1999), cited by 1
- K946352: Lemaitre Valvulotome II (1995), cited by 1
- K925283: Valvulotome (1994), cited by 1
- K080178: Valvulotome by Koven (2008), cited by 1
- K132047: Lemills Valvulotome (2013), cited by 1

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