510(k) K231774 · FGB Ureteroscope And Accessories, Flexible/Rigid
CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B)
| Applicant | MacroLux Medical Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 11, 2024 |
| Received | Jun 16, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231774
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.