510(k) K221158 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Single-Use Video Flexible Ureterorenoscope System
| Applicant | Guangzhou Red Pine Medical Instrument Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Mar 6, 2023 |
| Received | Apr 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221158
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.