Clearance Summary
SIRIUS Endoscope System (PR-SI-1230) received FDA 510(k) clearance under submission number K250939, sponsored by Precision Robotics (Hong Kong) Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-08-29.
- Submission: K250939
- Applicant / Sponsor: Precision Robotics (Hong Kong) Limited
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 2025-08-29
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.