# PNL: Magnetic Surgical System

- Device class: 2; regulation: 21 CFR 878.4815; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 87 days (middle half 72–164)
- 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)
- 2016: 1
- 2017: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2023: 1
- 2025: 2

## Most-cited predicates
- DEN150007: Magnetic Surgical System (2016), cited by 3
- K250746: Magnetic Surgical System (2025), cited by 1
- K190006: Magnetic Surgical System (2019), cited by 1
- K191762: Magnetic Surgical System (2020), cited by 1
- K180894: Magnetic Surgical System (2018), cited by 1
- K171429: Magnetic Surgical System (2017), cited by 1

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