# MLZ: Vitrectomy, Instrument Cutter

- Device class: 2; regulation: 21 CFR 886.4150; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 119 days (middle half 119–119)
- 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)
- 2008: 1
- 2010: 1
- 2017: 1
- 2022: 1

## Most-cited predicates
- K093305: Enhanced Ultra Vit Probe (2010), cited by 4
- K170520: HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (2017), cited by 1

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