Intuitive IG1000 cleared by FDA

 

Intuitive Endoluminal Gastrointestinal System (IG1000) has received FDA 510(k) clearance. 

Manufacturer	Intuitive Surgical, Inc.
System	Intuitive Endoluminal Gastrointestinal System
Model	IG1000
FDA submission	K253702
Submission type	Traditional 510(k)
FDA receipt date	24 November 2025
Clearance date	7 August 2026
Decision	Substantially equivalent
Device class	Class II
Regulation	21 CFR 876.1500
Primary product code	FDS — flexible/rigid gastroscope and accessories
Secondary product code	FET — endoscopic video-imaging system/component
Intended anatomical area	Stomach/upper gastrointestinal tract
Access route	Transoral, based on the FDS classification

The product codes establish that IG1000 includes:

• a gastroscope or gastroscope-like instrument inserted orally into the stomach;
• equipment for examining or performing procedures in the stomach;
• an electronic endoscopic visualization chain projecting images to a monitor;
• potentially a camera, video processor, display, light source, software, pumps, or related hardware.

It is being speculated that the system may be a platform for a more complex robotic solution, opening entirely new clinical domains for Intuitive. 

Source: LinkedIn, Intuitive patent