Device product

Model No. CYF-5R, Cystonephrofiberscope

Z-0685-2024

December 04, 2023

Class II

Product summary

Firm: Shirakawa Olympus Co., Ltd.
Event: Event 93583
Status: Ongoing
Classification: Class II
Quantity: 2551 US; 3738 Global
Official record key: device-enforcement:Z-0685-2024

Official wording

Reason: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

Code information: UDI-DI: 04953170328817 04953170411182 All serial numbers

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.