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Sirius Pintuition

Sirius Medical Systems B.V. · Model Sirius Pintuition Seed 14G x 7cm · UDI-DI 08719992742882

PBY NEU Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the target tissue. The Sirius Pintuition Detector is intended only for the non-imaging detection and localization of the Sirius Pintuition Seed that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.