# K250432: Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: May 15, 2025 after 90 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: 11 generations back to K931154 (1993). 32 ancestors in all.
No later device cites it as a predicate yet.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222584: Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I, Gastrointestinal Videoscope Olympus Gif-1100, Olympus Medical Systems Corporation (2023) Summary page 6.

## Indications for use
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL & CF-EZ1500DI are intended to be used with a video system center, endoscope position detecting unit, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

Source page: https://510kreport.com/device/K250432
Methodology: https://510kreport.com/methodology