FDA 510(k)

Accuro® 3S Needle Guide Kit

K-Number: K250469 · 2025-06-13

Decision Date2025-06-13

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Accuro® 3S Needle Guide Kit is a medical device manufactured by Rivanna Medical, Inc.. It received FDA 510(k) clearance on 2025-06-13 under approval number K250469. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accuro® 3S Needle Guide Kit?

Accuro® 3S Needle Guide Kit is a medical device that received FDA 510(k) clearance on 2025-06-13. It is manufactured by Rivanna Medical, Inc.. The 510(k) number is K250469.

When was Accuro® 3S Needle Guide Kit approved by the FDA?

Accuro® 3S Needle Guide Kit received FDA 510(k) clearance on 2025-06-13, under approval number K250469.

What company makes Accuro® 3S Needle Guide Kit?

Accuro® 3S Needle Guide Kit is manufactured by Rivanna Medical, Inc..

What is the FDA product code for Accuro® 3S Needle Guide Kit?

The FDA product code for Accuro® 3S Needle Guide Kit is ITX.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT02119611 Deep Brain Stimulation Therapy in Movement Disorders RECRUITING NCT06281249 Neuraxial Ultrasound Device Study NOT_YET_RECRUITING NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION

Other Devices by Rivanna Medical, Inc.

K243937Accuro 3S K254021Accuro XV

Related Devices (Code: ITX)

K152126UST-5550-R; UST-5536-R; L43KHitachi Aloka Medical America, Inc. K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc. K160414Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC K153212Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeKoelis K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.