# K043487: Evis Exera Colonovideoscope Model XCF-Q160W1L/1

- Pathway: 510(k) (Traditional)
- Applicant: Aizu Olympus Co., Ltd.
- Decided: Jan 28, 2005 after 42 days
- Product code: FDF (Colonoscope 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: 1 generation back to K001241 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000)

## Indications for use
This instrument has been designed to be used with the Olympus Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical Unit, Endo-therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid colon, and ileocecal valve).

Source page: https://510kreport.com/device/K043487
Methodology: https://510kreport.com/methodology