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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 / K253826

510(k) cleared

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle

Galvanize Therapeutics, Inc. · May 7, 2026 · K253826 · In the directory

FDA cleared the Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle from Galvanize Therapeutics, Inc. on May 7, 2026 under K253826, a traditional 510(k). The device falls under product code OAB, Low Energy Direct Current Thermal Ablation System, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 1, 2025. The decision came 157 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 Galvanize Therapeutics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253826?

K253826 is the FDA 510(k) for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle, submitted by Galvanize Therapeutics, Inc.. FDA's decision date was May 7, 2026, under product code OAB (Low Energy Direct Current Thermal Ablation System).

Who makes the Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle?

Galvanize Therapeutics, Inc., based in Redwood City, CA, is the applicant of record for K253826. The company is listed in the MedDevice Startups directory.

How long did the K253826 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on May 7, 2026, 157 days later.

← All decisions in May 2026

Sources

In the startup directory

Galvanize Therapeutics

Oncology · Redwood City, CA