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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 / June 2026 / K261772

510(k) cleared

Target Xtra Detachable Coil

Stryker Neurovscular · Jun 24, 2026 · K261772

FDA cleared the Target Xtra Detachable Coil from Stryker Neurovscular on Jun 24, 2026 under K261772, a special 510(k). The device falls under product code HCG, Device, Neurovascular Embolization, regulated at 21 CFR 882.5950 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 29, 2026. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Stryker Neurovscular in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261772?

K261772 is the FDA 510(k) for Target Xtra Detachable Coil, submitted by Stryker Neurovscular. FDA's decision date was Jun 24, 2026, under product code HCG (Device, Neurovascular Embolization).

Who makes the Target Xtra Detachable Coil?

Stryker Neurovscular, based in Fremont, CA, is the applicant of record for K261772.

How long did the K261772 review take?

FDA received the submission on May 29, 2026 and issued its decision on Jun 24, 2026, 26 days later.

← All decisions in June 2026