K250939
- 510(k) number
- K250939
- Device name
- SIRIUS Endoscope System (PR-SI-1230)
- Applicant
- Precision Robotics (Hong Kong) Limited HK
- Product code
- HET — Laparoscope, Gynecologic (And Accessories)
- Decision date
- 2025-08-29
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250939.pdf
Official FDA record: K250939
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.