510(k) K250917 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
| Applicant | Shenzhen Sanping Image Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Oct 31, 2025 |
| Received | Mar 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250917
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.