510(k) K250939 ยท HET Laparoscope, Gynecologic (And Accessories)
SIRIUS Endoscope System (PR-SI-1230)
| Applicant | Precision Robotics (Hong Kong) Limited, Hong Kong, HK |
| Decision | Substantially Equivalent, Aug 29, 2025 |
| Received | Mar 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250939
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.