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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 / K260317

510(k) cleared

Artelon Convenience Kits

International Life Sciences · Apr 9, 2026 · K260317

FDA cleared the Artelon Convenience Kits from International Life Sciences on Apr 9, 2026 under K260317, a traditional 510(k). The device falls under product code QWJ, Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament, regulated at 21 CFR 878.3300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jan 30, 2026. The decision came 69 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for International Life Sciences in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260317?

K260317 is the FDA 510(k) for Artelon Convenience Kits, submitted by International Life Sciences. FDA's decision date was Apr 9, 2026, under product code QWJ (Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament).

Who makes the Artelon Convenience Kits?

International Life Sciences, based in Sandy Springs, GA, is the applicant of record for K260317.

How long did the K260317 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Apr 9, 2026, 69 days later.

← All decisions in April 2026