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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 / K253663

510(k) cleared

Zeta Navigation System

Zeta Surgical, Inc. · May 1, 2026 · K253663 · In the directory

FDA cleared the Zeta Navigation System from Zeta Surgical, Inc. on May 1, 2026 under K253663, a traditional 510(k). The device falls under product code HAW, Neurological Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 20, 2025. The decision came 162 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zeta Surgical, Inc. has 2 other decisions in the tracker over the last 12 months: K261471 (Zeta TMS Navigation System), K251927 (Zeta Navigation System (ZNS131-US)).

Questions & Answers

What did FDA clear under K253663?

K253663 is the FDA 510(k) for Zeta Navigation System, submitted by Zeta Surgical, Inc.. FDA's decision date was May 1, 2026, under product code HAW (Neurological Stereotaxic Instrument).

Who makes the Zeta Navigation System?

Zeta Surgical, Inc., based in Boston, MA, is the applicant of record for K253663. The company is listed in the MedDevice Startups directory.

How long did the K253663 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on May 1, 2026, 162 days later.

← All decisions in May 2026

Sources

In the startup directory

Zeta Surgical

Surgical & Robotics · Boston, MA