# PUL: Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

- Device class: 2; regulation: 21 CFR 886.4100; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 117 days (middle half 88–194)
- Recalls: 0 (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)
- 2017: 1
- 2021: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- K210827: ZEPTO Precision Capsulotomy System (2021), cited by 2
- K170655: Zepto (2017), cited by 1

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