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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 / December 2025 / K250725

510(k) cleared

Hugo RAS System

Covidien, LLC · Dec 3, 2025 · K250725

FDA cleared the Hugo RAS System from Covidien, LLC on Dec 3, 2025 under K250725, a traditional 510(k). The device falls under product code SCV, Modular Electromechanical Surgical System, regulated at 21 CFR 878.4964 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 10, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Covidien, LLC has 8 other decisions in the tracker over the last 12 months: K260907 (BIS Advance pEEG Module), K253527 (Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)), K253984 (Instrument Exit Point on Touch Surgery Aide), K253030 (Capnostream35 Portable Respiratory Monitor (PM35MN)).

Questions & Answers

What did FDA clear under K250725?

K250725 is the FDA 510(k) for Hugo RAS System, submitted by Covidien, LLC. FDA's decision date was Dec 3, 2025, under product code SCV (Modular Electromechanical Surgical System).

Who makes the Hugo RAS System?

Covidien, LLC, based in North Haven, CT, is the applicant of record for K250725.

How long did the K250725 review take?

FDA received the submission on Mar 10, 2025 and issued its decision on Dec 3, 2025, 268 days later.

← All decisions in December 2025