K250939 is an FDA 510(k) clearance for the SIRIUS Endoscope System (PR-SI-1230). This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by Precision Robotics (Hong Kong) Limited (Hong Kong, HK). The FDA issued a Cleared decision on August 29, 2025, 154 days after receiving the submission on March 28, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K250939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2025 |
| Decision Date | August 29, 2025 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HET - Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1720 |