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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 / November 2025 / K251596

510(k) cleared

Lunderquist Extra Stiff Wire Guide

William Cook Europe Aps · Nov 9, 2025 · K251596

FDA cleared the Lunderquist Extra Stiff Wire Guide from William Cook Europe Aps on Nov 9, 2025 under K251596, a special 510(k). The device falls under product code DQX, Wire, Guide, Catheter, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 27, 2025. The decision came 166 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 William Cook Europe Aps in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251596?

K251596 is the FDA 510(k) for Lunderquist Extra Stiff Wire Guide, submitted by William Cook Europe Aps. FDA's decision date was Nov 9, 2025, under product code DQX (Wire, Guide, Catheter).

Who makes the Lunderquist Extra Stiff Wire Guide?

William Cook Europe Aps, based in Bjaeverskov, is the applicant of record for K251596.

How long did the K251596 review take?

FDA received the submission on May 27, 2025 and issued its decision on Nov 9, 2025, 166 days later.

← All decisions in November 2025