# K032177: Gastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope XCF-Q14ML/I, XPCF-160AML/I

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Opto-Electronics Co., Ltd.
- Decided: Oct 2, 2003 after 78 days
- Product code: FDS (Gastroscope 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: 2 generations back to K853585 (1986). 4 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954451: Evis 140 System, Olympus America, Inc. (1996) Summary page 2.
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000)

## Most influential descendants
- K070330: Third Eye Retroscope Auxiliary Endoscopy System (2007), 13 descendants of its own
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own
- K121582: Invendo C25 Colonoscopy System (2012), 5 descendants of its own
- K083180: Third Eye Retroscope Auxiliary Endoscopy System (2009), 5 descendants of its own
- K091783: Third Eye Retroscope Auxiliary Endoscope System (2009), 4 descendants of its own

## 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 upper digestive tract (including the esophagus, stomach and duodenum). 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, colon, and ileocecal valve).

Source page: https://510kreport.com/device/K032177
Methodology: https://510kreport.com/methodology