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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 / May 2026 / K260695

510(k) cleared

da Vinci Firefly Imaging System

Intuitive Surgical · May 22, 2026 · K260695

FDA cleared the da Vinci Firefly Imaging System from Intuitive Surgical on May 22, 2026 under K260695, a traditional 510(k). The device falls under product code NAY, System, Surgical, Computer Controlled Instrument, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 3, 2026. The decision came 80 days later, inside the 90 FDA-day goal for a 510(k).

Intuitive Surgical 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)), K253986 (da Vinci Force Feedback Instruments).

Questions & Answers

What did FDA clear under K260695?

K260695 is the FDA 510(k) for da Vinci Firefly Imaging System, submitted by Intuitive Surgical. FDA's decision date was May 22, 2026, under product code NAY (System, Surgical, Computer Controlled Instrument).

Who makes the da Vinci Firefly Imaging System?

Intuitive Surgical, based in Sunnyvale, CA, is the applicant of record for K260695.

How long did the K260695 review take?

FDA received the submission on Mar 3, 2026 and issued its decision on May 22, 2026, 80 days later.

← All decisions in May 2026