510(k) K221642
K221642 is an FDA 510(k) premarket notification submitted by Precision Robotics (Hong Kong) Limited for the device "SIRIUS Endoscope System". The FDA issued a decision of Substantially Equivalent on December 12, 2022. 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
- December 12, 2022
- Date Received
- June 6, 2022
- 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