OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
FDA 510(k) clearance K221690 · decided 2022-12-29
Clearance details
- K-number
- K221690
- Device name
- OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-10
- Decision date
- 2022-12-29
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- FAJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Model No. CYF-5, Cystonephrofiberscope recall (Z-0684-2024) | Shirakawa Olympus Co., Ltd. | 2024-01-09 |
| Model No. CYF-5R, Cystonephrofiberscope recall (Z-0685-2024) | Shirakawa Olympus Co., Ltd. | 2024-01-09 |
| Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidne recall (Z-0331-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |