Accuro® 3S Needle Guide Kit— 510(k) K261014
Substantially EquivalentRivanna 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.
Summary
Rivanna Medical's Accuro 3S Needle Guide Kit is filed under ITX, diagnostic ultrasonic transducers. The device name describes a needle guide kit, which the code name doesn't mention, and the record doesn't list the kit's contents.
Class II, 21 CFR 892.1570. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Rivanna Medical filed from Charlottesville, Virginia. Review took 119 calendar days (March 27 to July 24, 2026).
Clearance details
- Applicant
- Rivanna Medical, Inc.
- Product code
- Product code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottesville, VA, US
Recent devices under product code ITX
view allMore clearances from Rivanna Medical, Inc.
view allAdverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . 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.