# K221690: Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R), Light Guide Adapter (Maj-1413)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Dec 29, 2022 after 202 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (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.
No later device cites it as a predicate yet.
1 of 20 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 5.

## Recalls of this device
- Dec 4, 2023 · Class II · Z-0684-2024: 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-0685-2024: 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
OES CYSTONEPHROFIBERSCOPEs OLYMPUS CYF-5 and CYF-5R have been designed to be used with an Olympus light source, documentation equipment, display monitor, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.

Source page: https://510kreport.com/device/K221690
Methodology: https://510kreport.com/methodology