510(k) K262437 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)
| Applicant | Zhejiang Geyi Medical Instrument Co., Ltd., Jiande City, CN |
| Decision | Substantially Equivalent, Oct 29, 2026 |
| Received | Jul 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262437
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.