# Sirius Medical Systems B.V.

- Location (FDA's records): Eindhoven, NL
- FDA decisions: 3 (2021–2023): 3 510(k) clearances
- Product codes: PBY (3)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Endomagnetics Ltd.,: 1 (https://510kreport.com/company/endomagnetics)

## Its most-cited devices
- K222643: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (2022), cited by 1
- K200734: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (2021), cited by 1

## Recent decisions
- K223682: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (Nov 9, 2023)
- K222643: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (Oct 19, 2022)
- K200734: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (Feb 24, 2021)

Source page: https://510kreport.com/company/sirius-medical-systems