# K130259: Bearing Nspva Embolization Particles

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jun 7, 2013 after 126 days
- Product code: NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961923 (1996). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100663: Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321, Boston Scientific Corporation (2010) Summary page 1.

## Most influential descendants
- K233813: Bearing nsPVA Express™ (2023), 0 descendants of its own

## Indications for use
Bearing™ nsPVA Embolization Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

Source page: https://510kreport.com/device/K130259
Methodology: https://510kreport.com/methodology