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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 / K261471

510(k) cleared

Zeta TMS Navigation System

Zeta Surgical, Inc. · Jul 9, 2026 · K261471 · In the directory

FDA cleared the Zeta TMS Navigation System from Zeta Surgical, Inc. on Jul 9, 2026 under K261471, a special 510(k). The device falls under product code QFF, Electromechanical Arm For A Transcranial Magnetic Stimulation System, regulated at 21 CFR 882.5805 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 4, 2026. The decision came 66 days later, inside the 90 FDA-day goal for a 510(k).

Zeta Surgical, Inc. has 2 other decisions in the tracker over the last 12 months: K253663 (Zeta Navigation System), K251927 (Zeta Navigation System (ZNS131-US)).

Questions & Answers

What did FDA clear under K261471?

K261471 is the FDA 510(k) for Zeta TMS Navigation System, submitted by Zeta Surgical, Inc.. FDA's decision date was Jul 9, 2026, under product code QFF (Electromechanical Arm For A Transcranial Magnetic Stimulation System).

Who makes the Zeta TMS Navigation System?

Zeta Surgical, Inc., based in Boston, MA, is the applicant of record for K261471. The company is listed in the MedDevice Startups directory.

How long did the K261471 review take?

FDA received the submission on May 4, 2026 and issued its decision on Jul 9, 2026, 66 days later.

← All decisions in July 2026

Sources

In the startup directory

Zeta Surgical

Surgical & Robotics · Boston, MA