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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 / October 2025 / K250126

510(k) cleared

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)

Livsmed, Inc. · Oct 21, 2025 · K250126

FDA cleared the ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) from Livsmed, Inc. on Oct 21, 2025 under K250126, 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 Jan 17, 2025. The decision came 277 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 Livsmed, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250126?

K250126 is the FDA 510(k) for ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M), submitted by Livsmed, Inc.. FDA's decision date was Oct 21, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)?

Livsmed, Inc., based in Seongnam-Si, is the applicant of record for K250126.

How long did the K250126 review take?

FDA received the submission on Jan 17, 2025 and issued its decision on Oct 21, 2025, 277 days later.

← All decisions in October 2025