# NCR: Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered

- Device class: 2; regulation: 21 CFR 886.4100; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2000: 1
- 2004: 1
- 2005: 1

## Most-cited predicates
- K001498: The Fugo Blade (2000), cited by 5
- K041019: The Fugo Blade for Glaucoma (2004), cited by 1
- K050933: Fugo Blade for Peripheral Iridotomy, Model M300 (2005), cited by 1

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