510(k) K221690 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Dec 29, 2022 |
| Received | Jun 10, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221690
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2024 | Shirakawa Olympus Co., Ltd. Model No. CYF-5, Cystonephrofiberscope Open, Classified |
FAJ | None listed |
| Jan 9, 2024 | Shirakawa Olympus Co., Ltd. Model No. CYF-5R, Cystonephrofiberscope Open, Classified |
FAJ | None listed |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney
Model Numbers: CYF-5, CYF-VH, CYF-VHR. Open, Classified |
FAJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.