# K222643: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

- Pathway: 510(k) (Special)
- Applicant: Sirius Medical Systems B.V.
- Decided: Oct 19, 2022 after 48 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: 10 generations back to K023694 (2003). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200734: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit, Sirius Medical Systems B.V. (2021) Summary page 4.

## Most influential descendants
- K223682: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (2023), 0 descendants of its own

## Indications for use
The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark temporarily (<30 days) a lumpectomy site inteded for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed can be located and surgically removed with the target tissue. The Sirius Pintuition Detector is intended for the non-imaging detection and localization of the Sirius Pintuition Seed that has been implanted in a lumpectomy site intended for surgical removal.

Source page: https://510kreport.com/device/K222643
Methodology: https://510kreport.com/methodology