Visera Cystovideoscope Olympus Cyf Type V/VA

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K021074 ↗

FDA Product Code

FAJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Olympus America, Inc. →

• What is the VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA used for?

  It is used for visualization and treatment within the bladder and urethra, capturing optical images via an integrated CCD sensor that replaces traditional fiber-optic image guides to provide improved resolution in urology and gastroenterology settings.

• How is the VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA supplied and what type of device is it?

  It is supplied as a flexible endoscope for use in gastroenterology and urology settings, classified as a cystoscope and accessories, flexible/rigid, designed for direct visualization and intervention in the urinary tract.

• What regulatory pathway was used for the VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA and what is its classification?

  It was authorized under FDA 510(k) clearance K021074, classified as a Class II device under regulation number 876.1500 with product code FAJ, based on a determination of substantial equivalence to a legally marketed predicate device.