Cleared Traditional

Accuro? 3S Needle Guide Kit

K250469 · Rivanna Medical, Inc. · Radiology

Jun 2025

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K250469 is an FDA 510(k) clearance for the Accuro? 3S Needle Guide Kit, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Rivanna Medical, Inc. (Charlottesville, US). The FDA issued a Cleared decision on June 13, 2025, 115 days after receiving the submission on February 18, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number	K250469 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2025
Decision Date	June 13, 2025
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF