Accuro 3S— 510(k) K253452

Name: FDA 510(k) clearance K253452
Creator: U.S. Food and Drug Administration
Published: 2026-07-24

Substantially Equivalent

Rivanna Medical, Inc.

FDA 510(k) clearance K253452 for Accuro 3S, Substantially Equivalent on 2026-07-24. Applicant: Rivanna Medical, Inc.. Device class: 2.

Clearance details

Applicant: Rivanna Medical, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2025-10-06
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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K260190 — ARTHUR2026-06-18
K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04
K253714 — IntraSight Plus2026-02-24

More clearances from Rivanna Medical, Inc.

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K261014 — Accuro® 3S Needle Guide Kit2026-07-24
K250469 — Accuro® 3S Needle Guide Kit2025-06-13
K243937 — Accuro 3S2025-05-23

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.