# K253702: Intuitive Endoluminal Gastrointestinal System (IG1000)

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Aug 7, 2026 after 256 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: 5 generations back to K944759 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210162: Endoscope Model EI-740D/S, Fujifilm Corporation (2021) Summary page 5.

## Indications for use
The Intuitive Endoluminal Gastrointestinal (Gl) System is intended for the robotic-assisted control of the Robotic GI Endoscope during visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum.

Source page: https://510kreport.com/device/K253702
Methodology: https://510kreport.com/methodology