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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 / February 2026 / K253978

510(k) cleared

Universal Seal (5-12 mm)

Intuitive Surgical, Inc. · Feb 24, 2026 · K253978

FDA cleared the Universal Seal (5-12 mm) from Intuitive Surgical, Inc. on Feb 24, 2026 under K253978, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 12, 2025. The decision came 74 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 K253978?

K253978 is the FDA 510(k) for Universal Seal (5-12 mm), submitted by Intuitive Surgical, Inc.. FDA's decision date was Feb 24, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Universal Seal (5-12 mm)?

Intuitive Surgical, Inc., based in Sunnyvale, CA, is the applicant of record for K253978.

How long did the K253978 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Feb 24, 2026, 74 days later.

← All decisions in February 2026