510(k) K243708 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)
| Applicant | Scivita Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Mar 27, 2025 |
| Received | Dec 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243708
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.