510(k) K252468 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)
| Applicant | Zhejiang Geyi Medical Instrument Co., Ltd., Jiande City, CN |
| Decision | Substantially Equivalent, Dec 16, 2025 |
| Received | Aug 6, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252468
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.