# K163541: Magseed Magnetic Marker System

- Pathway: 510(k) (Special)
- Applicant: Endomagnetics Ltd.,
- Decided: Jan 13, 2017 after 28 days
- Product code: PBY (Temporary Tissue Marker)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K023694 (2003). 22 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153044: Sentimag System, Sentimark Magnetic Marker Systerm, Endomagnetics Ltd., (2016) Summary page 5.

## Most influential descendants
- K210600: MOLLI (2021), 5 descendants of its own
- K223107: MOLLI 2 (2023), 4 descendants of its own
- K231579: MOLLI 2 (2023), 3 descendants of its own
- K200734: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (2021), 2 descendants of its own
- K173587: Magseed Magnetic Marker Systtem (2018), 2 descendants of its own

## Indications for use
The Endomag Magseed Magnetic Marker is intended to be placed percutaneously in the breast to mark temporarily (< 30 days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimag® System) the Endomag Magseed Magnetic Marker is located and surgically removed with the target tissue. The Endomag Sentimag® System is intended for the non-imaging detection and localization of the "Endomag Magseed Magnetic Marker" that has been implanted in a lumpectomy site intended for surgical removal.

Source page: https://510kreport.com/device/K163541
Methodology: https://510kreport.com/methodology