510(k) K250939
K250939 is an FDA 510(k) premarket notification submitted by Precision Robotics (Hong Kong) Limited for the device "SIRIUS Endoscope System (PR-SI-1230)". The FDA issued a decision of Substantially Equivalent on August 29, 2025. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Precision Robotics (Hong Kong) Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2025
- Date Received
- March 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1720
- Review Panel
- OB
- Submission Type