K250469 is an FDA 510(k) clearance for the Accuro® 3S Needle Guide Kit. This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K250469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | ITX - Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |