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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 / March 2026 / K253680

510(k) cleared

LYNX COBLATION Laryngeal Wand (72290254)

ArthroCare Corporation · Mar 25, 2026 · K253680

FDA cleared the LYNX COBLATION Laryngeal Wand (72290254) from ArthroCare Corporation on Mar 25, 2026 under K253680, 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 Nov 21, 2025. The decision came 124 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ArthroCare Corporation has one other decision in the tracker over the last 12 months: K254122 (FLOW FLEXTEND Wand (72290039)).

Questions & Answers

What did FDA clear under K253680?

K253680 is the FDA 510(k) for LYNX COBLATION Laryngeal Wand (72290254), submitted by ArthroCare Corporation. FDA's decision date was Mar 25, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the LYNX COBLATION Laryngeal Wand (72290254)?

ArthroCare Corporation, based in Austin, TX, is the applicant of record for K253680.

How long did the K253680 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Mar 25, 2026, 124 days later.

← All decisions in March 2026

Sources