# NLQ: Single-Use Reprocessed Ultrasonic Surgical Instruments

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 130 days (middle half 96–155)
- Recalls: 3 (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)
- 2014: 3
- 2015: 2
- 2016: 1
- 2017: 3
- 2018: 1
- 2019: 2
- 2020: 1
- 2021: 1
- 2024: 2
- 2025: 1

## Most-cited predicates
- K202554: Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis (2021), cited by 1
- K233471: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) (2024), cited by 1

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