Accuro® 3S Needle Guide Kit— 510(k) K261014

Name: FDA 510(k) clearance K261014
Creator: U.S. Food and Drug Administration
Published: 2026-07-24

Substantially Equivalent

Rivanna Medical, Inc.

FDA 510(k) clearance K261014 for Accuro® 3S Needle Guide Kit, Substantially Equivalent on 2026-07-24. Applicant: Rivanna Medical, Inc.. Device class: 2.

Clearance details

Applicant: Rivanna Medical, Inc.
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2026-03-27
Decision date: 2026-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.