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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 / September 2025 / K252528

510(k) cleared

Ion Endoluminal System (IF1000)

Intuitive Surgical, Inc. · Sep 5, 2025 · K252528

FDA cleared the Ion Endoluminal System (IF1000) from Intuitive Surgical, Inc. on Sep 5, 2025 under K252528, a special 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Aug 11, 2025. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).

Intuitive Surgical, Inc. has 8 other decisions in the tracker over the last 12 months: K253702 (Intuitive Endoluminal Gastrointestinal System (IG1000)), K261824 (da Vinci Surgical System, Model IS5000), K261249 (Universal Seal (5-12 mm)), K260695 (da Vinci Firefly Imaging System).

Questions & Answers

What did FDA clear under K252528?

K252528 is the FDA 510(k) for Ion Endoluminal System (IF1000), submitted by Intuitive Surgical, Inc.. FDA's decision date was Sep 5, 2025, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the Ion Endoluminal System (IF1000)?

Intuitive Surgical, Inc., based in Sunnyvale, CA, is the applicant of record for K252528.

How long did the K252528 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Sep 5, 2025, 25 days later.

← All decisions in September 2025