510(k) K243155 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
| Applicant | Dongguan Zsr Biomedical Technology Company Limited, Dongguan, CN |
| Decision | Substantially Equivalent, Feb 11, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243155
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.