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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 / July 2026 / K260804

510(k) cleared

Anovo Surgical System (6Ne)

Momentis Surgical , Ltd. · Jul 22, 2026 · K260804

FDA cleared the Anovo Surgical System (6Ne) from Momentis Surgical , Ltd. on Jul 22, 2026 under K260804, a traditional 510(k). The device falls under product code SCV, Modular Electromechanical Surgical System, regulated at 21 CFR 878.4964 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 12, 2026. The decision came 132 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Momentis Surgical , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260804?

K260804 is the FDA 510(k) for Anovo Surgical System (6Ne), submitted by Momentis Surgical , Ltd.. FDA's decision date was Jul 22, 2026, under product code SCV (Modular Electromechanical Surgical System).

Who makes the Anovo Surgical System (6Ne)?

Momentis Surgical , Ltd., based in Or Yehuda, is the applicant of record for K260804.

How long did the K260804 review take?

FDA received the submission on Mar 12, 2026 and issued its decision on Jul 22, 2026, 132 days later.

← All decisions in July 2026