# NAJ: Agents, Embolic, For Treatment Of Uterine Fibroids

- Device class: 2; regulation: 21 CFR 870.3300; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 21 days (middle half 21–21)
- 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)
- 2002: 1
- 2003: 1
- 2008: 1
- 2010: 1
- 2013: 1
- 2014: 1
- 2018: 1
- 2023: 1

## Most-cited predicates
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization (2002), cited by 10
- K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter (2003), cited by 6
- K173871: CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres (2018), cited by 3
- K130259: Bearing Nspva Embolization Particles (2013), cited by 1
- K100663: Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321 (2010), cited by 1
- K133447: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres (2014), cited by 1

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