510(k) K250469

Accuro® 3S Needle Guide Kit by Rivanna Medical, Inc. — Product Code ITX

K250469 is an FDA 510(k) premarket notification submitted by Rivanna Medical, Inc. for the device "Accuro® 3S Needle Guide Kit". The FDA issued a decision of Substantially Equivalent on June 13, 2025. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Rivanna Medical, Inc. has at least 4 other 510(k) clearances on record.