510(k) K260516 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
| Applicant | MacroLux Medical Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 20, 2026 |
| Received | Feb 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260516
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.