# K993041: Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary Equipment

- Pathway: 510(k) (Traditional)
- Applicant: The Olympus Optical Co.
- Decided: Mar 30, 2000 after 202 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K843084 (1985). 2 ancestors in all.
271 later devices descend from it; 3 cite it directly.
5 of 274 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843084: Olympus CHP-P10 Nephroscope/Cystoscope, Olympus Corp. (1985) Summary page 5.
- K904940: Olympus Infant Resectoscope and Accessories, Olympus Corp. (1992) Summary page 5.
- (no number) Olympus XCYF-113: named in the summary without a submission number
- (no number) Olympus Nephroscope/Cystoscope Model CHF-P10: named in the summary without a submission number

## Most influential descendants
- K021074: Visera Cystovideoscope Olympus Cyf Type V/VA (2002), 268 descendants of its own
- 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

## Recalls of this device
- Apr 20, 2022 · Class II · Z-1262-2022: Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintent

## Indications for use
These instruments have been designed to be used with an Olympus Light Source, Documentation Equipment, Display Monitor, Suction Pump, Endo—Therapy Accessories, elecrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, and kidneys. Do not use this instrument for any purpose other than its intended use.

Source page: https://510kreport.com/device/K993041
Methodology: https://510kreport.com/methodology