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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 / K252087

510(k) cleared

Navigation Module of the Cortium® System

Ulrich Medical USA, Inc. · Feb 3, 2026 · K252087

FDA cleared the Navigation Module of the Cortium® System from Ulrich Medical USA, Inc. on Feb 3, 2026 under K252087, a traditional 510(k). The device falls under product code OLO, Orthopedic 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 Jul 2, 2025. The decision came 216 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ulrich Medical USA, Inc. has 2 other decisions in the tracker over the last 12 months: K252281 (ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)), K251295 (ulrichINJECT CT Motion (XD 8000)).

Questions & Answers

What did FDA clear under K252087?

K252087 is the FDA 510(k) for Navigation Module of the Cortium® System, submitted by Ulrich Medical USA, Inc.. FDA's decision date was Feb 3, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Navigation Module of the Cortium® System?

Ulrich Medical USA, Inc., based in Plano, TX, is the applicant of record for K252087.

How long did the K252087 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Feb 3, 2026, 216 days later.

← All decisions in February 2026

Sources