# K232865: Magseed Pro Magnetic Marker System

- Pathway: 510(k) (Traditional)
- Applicant: Endomagnetics Ltd.,
- Decided: Jun 28, 2024 after 287 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K023694 (2003). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173587: Magseed Magnetic Marker Systtem, Endomagnetics Ltd., (2018) Summary page 4.
- K073095: Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560, Somatex Medical Technologies GmbH (2008) Summary page 4.

## Recalls of this device
- Oct 1, 2025 · Class II · Z-0316-2026: Potential for contamination with cotton fibers.
- Oct 1, 2025 · Class II · Z-0317-2026: Potential for contamination with cotton fibers.

## Indications for use
The Endomag Magseed Pro Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Source page: https://510kreport.com/device/K232865
Methodology: https://510kreport.com/methodology