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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 / October 2025 / K250203

510(k) cleared

SureAx-Guide

Sureax Medical, LLC · Oct 17, 2025 · K250203

FDA cleared the SureAx-Guide from Sureax Medical, LLC on Oct 17, 2025 under K250203, a traditional 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 Jan 24, 2025. The decision came 266 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 Sureax Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250203?

K250203 is the FDA 510(k) for SureAx-Guide, submitted by Sureax Medical, LLC. FDA's decision date was Oct 17, 2025, under product code DQX (Wire, Guide, Catheter).

Who makes the SureAx-Guide?

Sureax Medical, LLC, based in San Diego, CA, is the applicant of record for K250203.

How long did the K250203 review take?

FDA received the submission on Jan 24, 2025 and issued its decision on Oct 17, 2025, 266 days later.

← All decisions in October 2025