WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K261014

510(k) cleared

Accuro® 3S Needle Guide Kit

Rivanna Medical, Inc. · Jul 24, 2026 · K261014

FDA cleared the Accuro® 3S Needle Guide Kit from Rivanna Medical, Inc. on Jul 24, 2026 under K261014, 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 Mar 27, 2026. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Rivanna Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K253452 (Accuro 3S), K254021 (Accuro XV).

Questions & Answers

What did FDA clear under K261014?

K261014 is the FDA 510(k) for Accuro® 3S Needle Guide Kit, submitted by Rivanna Medical, Inc.. FDA's decision date was Jul 24, 2026, under product code ITX (Transducer, Ultrasonic, Diagnostic).

Who makes the Accuro® 3S Needle Guide Kit?

Rivanna Medical, Inc., based in Charlottesville, VA, is the applicant of record for K261014.

How long did the K261014 review take?

FDA received the submission on Mar 27, 2026 and issued its decision on Jul 24, 2026, 119 days later.

← All decisions in July 2026

Sources