Clearance Summary
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit received FDA 510(k) clearance under submission number K222643, sponsored by Sirius Medical Systems B.V.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2022-10-19.
- Submission: K222643
- Applicant / Sponsor: Sirius Medical Systems B.V.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2022-10-19
Classification & Regulation
This clearance is catalogued under FDA product code PBY and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.