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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 / April 2026 / K253917

510(k) cleared

ARION ARC System

Plasma Surgical, Inc. · Apr 10, 2026 · K253917

FDA cleared the ARION ARC System from Plasma Surgical, Inc. on Apr 10, 2026 under K253917, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 8, 2025. The decision came 123 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 Plasma Surgical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253917?

K253917 is the FDA 510(k) for ARION ARC System, submitted by Plasma Surgical, Inc.. FDA's decision date was Apr 10, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the ARION ARC System?

Plasma Surgical, Inc., based in Roswell, GA, is the applicant of record for K253917.

How long did the K253917 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Apr 10, 2026, 123 days later.

← All decisions in April 2026