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Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / July 2026 / K261113

510(k) cleared

Op.n Spine Navigation and Robotic Guidance

Ecential Robotics · Jul 22, 2026 · K261113 · In the directory

FDA cleared the Op.n Spine Navigation and Robotic Guidance from Ecential Robotics on Jul 22, 2026 under K261113, 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 Apr 3, 2026. The decision came 110 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 Ecential Robotics in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261113?

K261113 is the FDA 510(k) for Op.n Spine Navigation and Robotic Guidance, submitted by Ecential Robotics. FDA's decision date was Jul 22, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Op.n Spine Navigation and Robotic Guidance?

Ecential Robotics, based in Gieres, is the applicant of record for K261113. The company is listed in the MedDevice Startups directory.

How long did the K261113 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on Jul 22, 2026, 110 days later.

← All decisions in July 2026

Sources

In the startup directory

eCential Robotics

Surgical & Robotics · Grenoble, France