510(k) K172246 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
OLYMPUS URF-V2/V2R
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Mar 30, 2018 |
| Received | Jul 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172246
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney.
Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R. Open, Classified |
FGB | None listed |
| Mar 25, 2022 | Olympus Corporation of the Americas Olympus Uretero-reno videoscope, Model No. URF-V2 Open, Classified |
NWB | None listed |
| Jan 17, 2018 | Olympus Corporation of the Americas Uretero-reno videoscope URF-V2
Uretero-reno videoscope URF-V2R Terminated |
OCS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.