FDA-Device2023-11-29Class II
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.
Aizu Olympus Co., Ltd.
Hazard
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Sold states
Worldwide - US Nationwide distribution.
Affected count
N/A
Manufactured in
3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, Japan
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0348-2024Don't want to check this manually?
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