SIRIUS Endoscope System (PR-SI-1230)
FDA 510(k) clearance K250939 · decided 2025-08-29
Clearance details
- K-number
- K250939
- Device name
- SIRIUS Endoscope System (PR-SI-1230)
- Applicant
- Precision Robotics (Hong Kong) Limited
- Decision
- Substantially Equivalent
- Date received
- 2025-03-28
- Decision date
- 2025-08-29
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Hong Kong, HK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.