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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 / September 2025 / K250209

510(k) cleared

Polyvinyl Alcohol Embolic Microspheres

Canyon Medical, Inc. · Sep 23, 2025 · K250209

FDA cleared the Polyvinyl Alcohol Embolic Microspheres from Canyon Medical, Inc. on Sep 23, 2025 under K250209, a traditional 510(k). The device falls under product code KRD, Device, Vascular, For Promoting Embolization, regulated at 21 CFR 870.3300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 24, 2025. The decision came 242 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 Canyon Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250209?

K250209 is the FDA 510(k) for Polyvinyl Alcohol Embolic Microspheres, submitted by Canyon Medical, Inc.. FDA's decision date was Sep 23, 2025, under product code KRD (Device, Vascular, For Promoting Embolization).

Who makes the Polyvinyl Alcohol Embolic Microspheres?

Canyon Medical, Inc., based in Nanjing, is the applicant of record for K250209.

How long did the K250209 review take?

FDA received the submission on Jan 24, 2025 and issued its decision on Sep 23, 2025, 242 days later.

← All decisions in September 2025