# K260824: Gastrointestinal Videoscope Olympus GIF-2T1500

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Aug 27, 2026 after 167 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: 6 generations back to K944759 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221551: FUJIFILM Endoscope Model EI-740D/S, Fujifilm Corporaton (2023) Summary page 5.

## Indications for use
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-2T1500 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. This instrument is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

Source page: https://510kreport.com/device/K260824
Methodology: https://510kreport.com/methodology