# K021074: Visera Cystovideoscope Olympus Cyf Type V/VA

- Pathway: 510(k) (Special)
- Applicant: Olympus America, Inc.
- Decided: May 2, 2002 after 30 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931154 (1993). 10 ancestors in all.
268 later devices descend from it; 5 cite it directly.
6 of 279 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993041: Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary Equipment, The Olympus Optical Co. (2000) Summary page 4.
- K912120: Urf-P2 Ureterorenofiberscope/Choledochofiberscope, Olympus Corp. (1991) Summary page 4.
- K931154: Evis 200 System, Olympus Corp. (1993) Summary page 4.
- K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment, The Olympus Optical Co. (1998) Summary page 4.

## Most influential descendants
- K062049: Evis Exera II 180 System (2006), 158 descendants of its own
- K100584: Evis Exeraii 180 System (2010), 132 descendants of its own
- K030960: Ecn Electronic Video Cystonephroscope (2003), 103 descendants of its own
- K042225: Acmi Invisio Icn, Models Icn-0564 and Icn-0565 (2004), 101 descendants of its own
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System (2006), 99 descendants of its own

## Indications for use
This instrument has been designed to be used with an Olymapus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder and urethra.

Source page: https://510kreport.com/device/K021074
Methodology: https://510kreport.com/methodology