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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 / K252317

510(k) cleared

Zenith Micro Guidewire

Suzhou Zenith Vascular SciTech Limited · Apr 16, 2026 · K252317

FDA cleared the Zenith Micro Guidewire from Suzhou Zenith Vascular SciTech Limited on Apr 16, 2026 under K252317, a traditional 510(k). The device falls under product code MOF, Guide, Wire, Catheter, Neurovasculature, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 25, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Suzhou Zenith Vascular SciTech Limited has 2 other decisions in the tracker over the last 12 months: K253359 (Zenith Distal Access Long Sheath), K252707 (Zenith Aspiration Catheter; Disposable Aspiration Tubing Set).

Questions & Answers

What did FDA clear under K252317?

K252317 is the FDA 510(k) for Zenith Micro Guidewire, submitted by Suzhou Zenith Vascular SciTech Limited. FDA's decision date was Apr 16, 2026, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the Zenith Micro Guidewire?

Suzhou Zenith Vascular SciTech Limited, based in Suzhou, is the applicant of record for K252317.

How long did the K252317 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Apr 16, 2026, 265 days later.

← All decisions in April 2026

Sources