510(k) K172298 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
OLYMPUS URF-P6/P6R
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Mar 29, 2018 |
| Received | Jul 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172298
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Ureteralscope- for endoscopic
diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).
Model Numbers: URF-P6, URF-P6R. Open, Classified |
FCB | None listed |
| Apr 20, 2022 | Olympus Corporation of the Americas Olympus URETERO-RENO FIBERSCOPE
Model: URF-P6 Open, Classified |
FGB | None listed |
| Apr 20, 2022 | Olympus Corporation of the Americas Olympus URETERO-RENO FIBERSCOPE
Model: URF-P6R Open, Classified |
FGB | None listed |
| Jan 17, 2018 | Olympus Corporation of the Americas Uretero-reno fiberscope URF-P6 Terminated |
FGB | None listed |
| Jan 17, 2018 | Olympus Corporation of the Americas Uretero-reno fiberscope URF-P6RP6 Terminated |
FGB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.