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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 / September 2025 / K251197

510(k) cleared

Dexter L6 System

Distalmotion SA · Sep 30, 2025 · K251197 · In the directory

FDA cleared the Dexter L6 System from Distalmotion SA on Sep 30, 2025 under K251197, a traditional 510(k). The device falls under product code SDD, Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field, regulated at 21 CFR 878.4965 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Apr 17, 2025. The decision came 166 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Distalmotion SA has 2 other decisions in the tracker over the last 12 months: K261398 (Dexter L6 System), K260653 (Dexter L6 System).

Questions & Answers

What did FDA clear under K251197?

K251197 is the FDA 510(k) for Dexter L6 System, submitted by Distalmotion SA. FDA's decision date was Sep 30, 2025, under product code SDD (Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field).

Who makes the Dexter L6 System?

Distalmotion SA, based in Epalinges, is the applicant of record for K251197. The company is listed in the MedDevice Startups directory.

How long did the K251197 review take?

FDA received the submission on Apr 17, 2025 and issued its decision on Sep 30, 2025, 166 days later.

← All decisions in September 2025

Sources

In the startup directory

Distalmotion

Surgical & Robotics · Lausanne, Switzerland