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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 / June 2026 / K261665

510(k) cleared

CORUS Navigation System-GN

Providence Medical Technology, Inc. · Jun 18, 2026 · K261665

FDA cleared the CORUS Navigation System-GN from Providence Medical Technology, Inc. on Jun 18, 2026 under K261665, a special 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 May 20, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Providence Medical Technology, Inc. has 2 other decisions in the tracker over the last 12 months: K253676 (CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)), K253190 (CORUS-LX Implant).

Questions & Answers

What did FDA clear under K261665?

K261665 is the FDA 510(k) for CORUS Navigation System-GN, submitted by Providence Medical Technology, Inc.. FDA's decision date was Jun 18, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the CORUS Navigation System-GN?

Providence Medical Technology, Inc., based in Pleasanton, CA, is the applicant of record for K261665.

How long did the K261665 review take?

FDA received the submission on May 20, 2026 and issued its decision on Jun 18, 2026, 29 days later.

← All decisions in June 2026

Sources