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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 / July 2026 / K262474

510(k) cleared

ND Needle Guidance System

Accurate Access, LLC · Jul 27, 2026 · K262474

FDA cleared the ND Needle Guidance System from Accurate Access, LLC on Jul 27, 2026 under K262474, a traditional 510(k). The device falls under product code ITX, Transducer, Ultrasonic, Diagnostic, regulated at 21 CFR 892.1570 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 17, 2026. The decision came 10 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Accurate Access, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262474?

K262474 is the FDA 510(k) for ND Needle Guidance System, submitted by Accurate Access, LLC. FDA's decision date was Jul 27, 2026, under product code ITX (Transducer, Ultrasonic, Diagnostic).

Who makes the ND Needle Guidance System?

Accurate Access, LLC, based in Paradise Valley, AZ, is the applicant of record for K262474.

How long did the K262474 review take?

FDA received the submission on Jul 17, 2026 and issued its decision on Jul 27, 2026, 10 days later.

← All decisions in July 2026