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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K253702

510(k) cleared

Intuitive Endoluminal Gastrointestinal System (IG1000)

Intuitive Surgical, Inc. · Aug 7, 2026 · K253702

FDA cleared the Intuitive Endoluminal Gastrointestinal System (IG1000) from Intuitive Surgical, Inc. on Aug 7, 2026 under K253702, a traditional 510(k). The device falls under product code FDS, Gastroscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Nov 24, 2025. The decision came 256 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Intuitive Surgical, Inc. has 8 other decisions in the tracker over the last 12 months: K261824 (da Vinci Surgical System, Model IS5000), K261249 (Universal Seal (5-12 mm)), K260695 (da Vinci Firefly Imaging System), K253986 (da Vinci Force Feedback Instruments).

Questions & Answers

What did FDA clear under K253702?

K253702 is the FDA 510(k) for Intuitive Endoluminal Gastrointestinal System (IG1000), submitted by Intuitive Surgical, Inc.. FDA's decision date was Aug 7, 2026, under product code FDS (Gastroscope And Accessories, Flexible/Rigid).

Who makes the Intuitive Endoluminal Gastrointestinal System (IG1000)?

Intuitive Surgical, Inc., based in Sunnyvale, CA, is the applicant of record for K253702.

How long did the K253702 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Aug 7, 2026, 256 days later.

← All decisions in August 2026