510(k) K231878 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Jul 25, 2023 |
| Received | Jun 26, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231878
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.