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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 / December 2025 / K252069

510(k) cleared

da Vinci SP Surgical System (SP1098)

Intuitive Surgical, Inc. · Dec 2, 2025 · K252069

FDA cleared the da Vinci SP Surgical System (SP1098) from Intuitive Surgical, Inc. on Dec 2, 2025 under K252069, 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 Jul 1, 2025. The decision came 154 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: 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 K252069?

K252069 is the FDA 510(k) for da Vinci SP Surgical System (SP1098), submitted by Intuitive Surgical, Inc.. FDA's decision date was Dec 2, 2025, under product code NAY (System, Surgical, Computer Controlled Instrument).

Who makes the da Vinci SP Surgical System (SP1098)?

Intuitive Surgical, Inc., based in Suunyvale, CA, is the applicant of record for K252069.

How long did the K252069 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Dec 2, 2025, 154 days later.

← All decisions in December 2025