510(k) K181451 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Jan 16, 2019 |
| Received | Jun 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181451
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.