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 s...
