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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 / December 2025 / K252694

510(k) cleared

Target Detachable Coil

Stryker Neurovascular · Dec 11, 2025 · K252694

FDA cleared the Target Detachable Coil from Stryker Neurovascular on Dec 11, 2025 under K252694, a traditional 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 Aug 26, 2025. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stryker Neurovascular has 3 other decisions in the tracker over the last 12 months: K261889 (Trevo Trak 21 Microcatheter), K253032 (AXS Lift Intracranial Base Catheter), K251832 (InZone IST Detachment System; IZDS Connecting Cable).

Questions & Answers

What did FDA clear under K252694?

K252694 is the FDA 510(k) for Target Detachable Coil, submitted by Stryker Neurovascular. FDA's decision date was Dec 11, 2025, under product code HCG (Device, Neurovascular Embolization).

Who makes the Target Detachable Coil?

Stryker Neurovascular, based in Fremont, CA, is the applicant of record for K252694.

How long did the K252694 review take?

FDA received the submission on Aug 26, 2025 and issued its decision on Dec 11, 2025, 107 days later.

← All decisions in December 2025

Sources