# K221683: CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jan 20, 2023 after 224 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931154 (1993). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133538: Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope Olympus Cyf Type VA2, Visera Cysto-NE, Olympus Corporation of the Americas (2014) Summary page 6.

## Most influential descendants
- K250269: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) (2025), 0 descendants of its own

## Recalls of this device
- Dec 4, 2023 · Class II · Z-0690-2024: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Dec 4, 2023 · Class II · Z-0691-2024: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Dec 4, 2023 · Class II · Z-0689-2024: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Dec 4, 2023 · Class II · Z-0692-2024: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Sep 25, 2023 · Class II · Z-0331-2024: 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 poten

## Indications for use
VISERA CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF TYPE V2, CYF TYPE V2R have been designed to be used with an Olympus video system center, ight source, documentation equipment, monitor, EndoTherapy accessores, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, and kidney. CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF VH, and CYF VHR have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, and kidney.

Source page: https://510kreport.com/device/K221683
Methodology: https://510kreport.com/methodology