510(k) K250049 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Vi
| Applicant | Seplou (Zhuhai) Co., Ltd., Zhuhai, CN |
| Decision | Substantially Equivalent, Aug 26, 2025 |
| Received | Jan 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250049
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.