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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 / K252880

510(k) cleared

Pytheas Your Guided Trajectory

Pytheas Navigation Sas · May 11, 2026 · K252880

FDA cleared the Pytheas Your Guided Trajectory from Pytheas Navigation Sas on May 11, 2026 under K252880, 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 Sep 10, 2025. The decision came 243 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 Pytheas Navigation Sas in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252880?

K252880 is the FDA 510(k) for Pytheas Your Guided Trajectory, submitted by Pytheas Navigation Sas. FDA's decision date was May 11, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Pytheas Your Guided Trajectory?

Pytheas Navigation Sas, based in Marseille, is the applicant of record for K252880.

How long did the K252880 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on May 11, 2026, 243 days later.

← All decisions in May 2026